Trial Outcomes & Findings for Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke (NCT NCT04919161)
NCT ID: NCT04919161
Last Updated: 2021-08-17
Results Overview
The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible. Admission and discharge Berg scores are collected from a chart review within 48 hours of participant discharge. The change in Berg score is calculated by subtracting the participants admission or pre-assessment score from their discharge or post-assessment score: (Post assessment)-(Pre assessment)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
The pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.
Results posted on
2021-08-17
Participant Flow
Recruitment occurred over 12 months, from October 2019 through September 2020. Participants were recruited from patients admitted to the inpatient stroke rehabilitation program at Gaylord Hospital after receiving a stroke diagnosis at a regional acute care hospital.
To be initially considered, patients had to be classified as a Moderate fall risk or better, shown by a Berg Balance Scale score of 21 or greater during their initial physical therapy evaluation. Patients who did not initially meet this criteria could screen-in at a later time pending a BBS reassessment. If the reassessment showed a sufficient functional improvement, and the patient had a discharge date of greater than two-weeks after the reassessment, the patient was recruited for the study.
Participant milestones
| Measure |
Body Weight Support System Control Group
In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.
Body weight support system (BWSS) control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations
Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.
Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level will be set based on the participant's progress.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Body Weight Support System Control Group
In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.
Body weight support system (BWSS) control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations
Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.
Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level will be set based on the participant's progress.
|
|---|---|---|
|
Overall Study
Early participant discharge from rehabilitation program after session 4
|
1
|
0
|
|
Overall Study
Flare-up of existing orthopedic condition after session 4
|
0
|
1
|
|
Overall Study
Acute ankle sprain after session 1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Body Weight Support System Control Group
n=16 Participants
In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.
Body weight support system control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations
n=16 Participants
Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.
Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level will be set based on the participant's progress.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=16 Participants
|
10 Participants
n=16 Participants
|
21 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=16 Participants
|
6 Participants
n=16 Participants
|
11 Participants
n=32 Participants
|
|
Age, Continuous
|
58.38 years
STANDARD_DEVIATION 12.71 • n=16 Participants
|
58.75 years
STANDARD_DEVIATION 15.43 • n=16 Participants
|
58.56 years
STANDARD_DEVIATION 13.90 • n=32 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
7 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
25 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: The pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.Population: The data from the 15 subjects from the BWSS control group and the 14 subjects from the BWSS-P who completed the study and were not withdrawn early, were included in this analysis.
The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible. Admission and discharge Berg scores are collected from a chart review within 48 hours of participant discharge. The change in Berg score is calculated by subtracting the participants admission or pre-assessment score from their discharge or post-assessment score: (Post assessment)-(Pre assessment)
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
|---|---|---|---|---|---|---|---|---|
|
Difference in Berg Balance Scale Pre-intervention and Post-intervention Assessment Scores
|
30.20 Score on a Scale
Interval 24.0 to 34.0
|
45.27 Score on a Scale
Interval 40.0 to 53.0
|
30.43 Score on a Scale
Interval 22.75 to 35.75
|
48.29 Score on a Scale
Interval 43.5 to 53.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.Population: The data from the 15 subjects from the BWSS control group and the 14 subjects from the BWSS-P who completed the study and were not withdrawn early, were included in this analysis.
The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible. Admission and discharge Berg scores are collected using from a chart review within 48 hours of participant discharge. The change in Berg score is calculated by subtracting the participants admission or pre-assessment score from their discharge or post-assessment score: (Post assessment) - (Pre assessment). The score change between groups was then compared between the two treatment groups
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of Berg Balance Scale Assessment Score Changes
|
15.07 Score on a Scale
Interval 11.0 to 19.0
|
17.86 Score on a Scale
Interval 9.0 to 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.Population: The data from the 15 subjects from the BWSS control group and the 14 subjects from the BWSS-P who completed the study and were not withdrawn early, were included in this analysis.
The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible. Admission and discharge Berg scores are collected using from a chart review within 48 hours of participant discharge. The BBS percent change is calculated using the following formula: \[((Post assessement)-(Pre assessment))/(Pre assessment)\] ×100%
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
|---|---|---|---|---|---|---|---|---|
|
Differences in the Percent Change of Berg Balance Scale (BBS) Assessment Scores
|
53.29 Percent Change
Interval 29.27 to 66.67
|
66.95 Percent Change
Interval 27.58 to 97.23
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The pre-assessment ABC is completed at participant enrollment just prior to first intervention. The post-assessment ABC is completed immediately after final intervention.Population: One participant in the Control group was discharged prior to completing the ABC post-assessment, resulting in an n=14.
The ABC Scale subjectively measures a person's self-perceived balance-confidence to perform various tasks without losing balance or experiencing a sense of unsteadiness; it is based on a rating scale from 0% (no confidence) to 100% (completely confident); higher the score the better.
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
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|---|---|---|---|---|---|---|---|---|
|
Activities-Specific Balance Confidence (ABC) Scale Score Change
|
20.57 Score on a Scale
Interval 2.29 to 34.11
|
20.96 Score on a Scale
Interval 6.793 to 35.16
|
—
|
—
|
—
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—
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—
|
—
|
SECONDARY outcome
Timeframe: The pre-assessment Toilet transfer score is collected during the initial occupational therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment is collected within 24 hours prior to discharge.Population: The data from the 15 subjects from the BWSS control group and the 14 subjects from the BWSS-P who completed the study and were not withdrawn early, were included in this analysis.
During their regular treatment, a modified functional independence measure, based on a scale of 0 (completely dependent) to 10 (completely independent), was used to assess each participant's assistance needs while undergoing toilet transfers. These scores were collected during a chart review conducted within 48 hours after participant discharge.
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
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|---|---|---|---|---|---|---|---|---|
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Toilet Transfer Score
|
4.300 Score on a Scale
Interval 4.0 to 4.5
|
7.7 Score on a Scale
Interval 7.0 to 8.0
|
4.893 Score on a Scale
Interval 4.0 to 5.0
|
8.393 Score on a Scale
Interval 8.0 to 9.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The pre-assessment Ambulation score is collected during the initial occupational therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment is collected within 24 hours prior to discharge.Population: The data from the 15 subjects from the BWSS control group and the 14 subjects from the BWSS-P who completed the study and were not withdrawn early, were included in this analysis.
During their regular treatment, a modified functional independence measure, based on a scale of 0 (completely dependent) to 10 (completely independent), was used to assess each participant's assistance needs while ambulating. These scores were collected during a chart review conducted within 48 hours after participant discharge.
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
|---|---|---|---|---|---|---|---|---|
|
Ambulation Score
|
4.357 Units on a Scale
Interval 3.0 to 6.0
|
7.800 Units on a Scale
Interval 6.0 to 9.0
|
4.750 Units on a Scale
Interval 4.0 to 7.0
|
8.643 Units on a Scale
Interval 6.0 to 10.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Perturbation level recordings completed for each of the 8 sessions completed over an average of 2 weeks.Population: This outcome only includes observations from the BWSS-P group as the BWSS control did not receive perturbations. Values for each of the 8 study sessions are shown. The perturbation level for the 6th session for one subject was not recorded and was left blank.
All participants started at perturbation level "one" and progressed up to a maximum perturbation level of "ten" through the course of the study; the higher the level,the more intense the exerted force. The amount of force exerted at each perturbation level is pre-set by the manufacturer.The highest perturbation level achieved by the participant achieved was recorded immediately after each intervention session. In total, 8 readings were collected for each BWSS-P participant for the 8 intervention sessions completed for the study.
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
n=14 Participants
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
n=14 Participants
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 6
n=13 Participants
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 7
n=14 Participants
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
BWSS-P (Perturbation Level Progression) Session 8
n=14 Participants
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
|
|---|---|---|---|---|---|---|---|---|
|
Perturbation Level Progression
|
1.857 Perturbation Level
Interval 1.0 to 4.0
|
3.143 Perturbation Level
Interval 1.0 to 6.0
|
4.429 Perturbation Level
Interval 2.0 to 7.0
|
4.929 Perturbation Level
Interval 2.0 to 8.0
|
5.571 Perturbation Level
Interval 3.0 to 10.0
|
6.077 Perturbation Level
Interval 3.0 to 10.0
|
6.5 Perturbation Level
Interval 4.0 to 10.0
|
6.875 Perturbation Level
Interval 4.0 to 10.0
|
POST_HOC outcome
Timeframe: This was conducted after the recruitment of the final participant.Population: This analysis was completed using the information from the participants who completed the study.
The proportion of males and females between treatment arms was evaluated
Outcome measures
| Measure |
Body Weight Support System Control Group (BBS Pre-score)
n=15 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System Control Group (BBS Post-score)
n=14 Participants
In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations (BBS Pre-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
Body Weight Support System With Balance Perturbations (BBS Post-score)
Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress.
|
BWSS-P (Perturbation Level Progression) Session 5
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
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BWSS-P (Perturbation Level Progression) Session 6
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
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BWSS-P (Perturbation Level Progression) Session 7
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
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BWSS-P (Perturbation Level Progression) Session 8
As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level "one" and progressed up to level "ten" as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants.
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Sex Differences Between Treatment Arms
Males
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13 Participants
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10 Participants
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—
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—
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—
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—
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—
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—
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Sex Differences Between Treatment Arms
Female
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2 Participants
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4 Participants
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—
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—
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—
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—
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—
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—
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Adverse Events
Body Weight Support System Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Body Weight Support System With Balance Perturbations
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Body Weight Support System Control Group
n=16 participants at risk
In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.
Body weight support system control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
|
Body Weight Support System With Balance Perturbations
n=16 participants at risk
Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.
Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level will be set based on the participant's progress.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Acute Ankle Sprain
|
0.00%
0/16 • Each participant was monitored for the occurrence of adverse events over the course of the two-week period in which they were participating in the study. Due to the nature of the intervention, monitoring for adverse events after the treatment course was unnecessary.
|
6.2%
1/16 • Number of events 1 • Each participant was monitored for the occurrence of adverse events over the course of the two-week period in which they were participating in the study. Due to the nature of the intervention, monitoring for adverse events after the treatment course was unnecessary.
|
|
Musculoskeletal and connective tissue disorders
Flare-up of pre-existing orthopedic condition
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0.00%
0/16 • Each participant was monitored for the occurrence of adverse events over the course of the two-week period in which they were participating in the study. Due to the nature of the intervention, monitoring for adverse events after the treatment course was unnecessary.
|
6.2%
1/16 • Number of events 1 • Each participant was monitored for the occurrence of adverse events over the course of the two-week period in which they were participating in the study. Due to the nature of the intervention, monitoring for adverse events after the treatment course was unnecessary.
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Additional Information
Dr. Henry C. Hrdlicka, Research Coordinator
Gaylord Hospital Inc.
Phone: 203-284-2864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place