Trial Outcomes & Findings for A Multisite Exploration of Balance Perturbations With and Without Body Weight Support (NCT NCT05110300)
NCT ID: NCT05110300
Last Updated: 2025-11-14
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Baseline (within 72 hours of admission)
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Body Weight Support System Control Group
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
57
|
|
Overall Study
COMPLETED
|
47
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multisite Exploration of Balance Perturbations With and Without Body Weight Support
Baseline characteristics by cohort
| Measure |
BWSS Patient Demographics
n=47 Participants
Demographics provided for all participants who were enrolled in the BWSS group.
|
BWSS-P Patient Demographics
n=52 Participants
Demographics provided for all participants who were enrolled in the BWSS-P group.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.36 years
STANDARD_DEVIATION 14.13 • n=10 Participants
|
65.04 years
STANDARD_DEVIATION 13.13 • n=10 Participants
|
63.77 years
STANDARD_DEVIATION 13.61 • n=20 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
33 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=10 Participants
|
35 Participants
n=10 Participants
|
66 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
28 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=10 Participants
|
35 Participants
n=10 Participants
|
68 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Berg Balance Scale
|
29.617 units on a scale
STANDARD_DEVIATION 8.581 • n=10 Participants
|
33.000 units on a scale
STANDARD_DEVIATION 8.623 • n=10 Participants
|
31.39 units on a scale
STANDARD_DEVIATION 8.726 • n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline (within 72 hours of admission)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.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Berg Balance Scale Pre-intervention Assessment Scores
|
29.62 score on a scale
Interval 27.1 to 32.14
|
33.00 score on a scale
Interval 30.6 to 35.4
|
PRIMARY outcome
Timeframe: The post-assessment BBS will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.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.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=52 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Berg Balance Scale Post-intervention Assessment Scores
|
43.85 score on a scale
Interval 41.91 to 45.79
|
45.40 score on a scale
Interval 43.65 to 47.16
|
PRIMARY outcome
Timeframe: The baseline pre-assessment BBS score will be collected within 72 hours of admission, as part of their normal care. The post-assessment will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.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
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=52 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Difference in Berg Balance Scale Pre-Intervention and Post-Intervention Assessment Scores
|
14.23 score on a scale
Interval 11.96 to 16.5
|
12.40 score on a scale
Interval 10.51 to 14.29
|
SECONDARY outcome
Timeframe: The pre-assessment ABC Scale will be collected within 48 hours of the first study session.The ABC scale is a 16-item patient reported outcome measure that subjectively measures ones self-perceived balance-confidence. The ABC achieves this by asking the user to consider various hypothetical situations and tasks and if the participants could perform the 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).
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Activities Specific Balance Scale (ABC) Pre-intervention Scores
|
56.35 score on a scale
Interval 48.93 to 63.76
|
61.53 score on a scale
Interval 53.79 to 69.26
|
SECONDARY outcome
Timeframe: The post-assessment ABC Scale will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.The ABC scale is a 16-item patient reported outcome measure that subjectively measures ones self-perceived balance-confidence. The ABC achieves this by asking the user to consider various hypothetical situations and tasks and if the participants could perform the 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).
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Activities Specific Balance Scale (ABC) Post-intervention Scores
|
75.58 score on a scale
Interval 70.14 to 81.03
|
78.54 score on a scale
Interval 72.96 to 84.12
|
SECONDARY outcome
Timeframe: The pre-assessment ABC Scale will be conducted within 48 hours prior to the first study session. The post-assessment ABC scale will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.The ABC scale is a 16-item patient reported outcome measure that subjectively measures ones self-perceived balance-confidence. The ABC achieves this by asking the user to consider various hypothetical situations and tasks and if the participants could perform the 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).
Outcome measures
| Measure |
Body Weight Support System Control Group
n=45 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=51 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Difference in Activities-Specific Balance Confidence (ABC) Scale Score Change
|
19.39 score on a scale
Interval 13.02 to 25.76
|
16.91 score on a scale
Interval 11.61 to 22.21
|
SECONDARY outcome
Timeframe: The pre-assessment 10MWT will be conducted by site investigators within 48 hours prior to the first study session.The 10MWT is used to assess walking speed in meters/second (m/s) over 10 meters (m). The time is started when any part of the leading foot crosses the plane of the 2 m mark. Time is stopped when any part of the leading foot crosses the plane of the 8 m mark. The total time taken to ambulate the central 6 m is recorded to the nearest hundredth of a second. 6 m is then divided by the total time and recorded in m/s (the faster the participant traverses 6 meters the better).
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
10 Meter Walk Test (10MWT) Pre-intervention Scores
|
.60 meters per second
Interval 0.5 to 0.7
|
.65 meters per second
Interval 0.53 to 0.77
|
SECONDARY outcome
Timeframe: The post-assessment 10MWT will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.The 10MWT is used to assess walking speed in meters/second (m/s) over 10 meters (m). The time is started when any part of the leading foot crosses the plane of the 2 m mark. Time is stopped when any part of the leading foot crosses the plane of the 8 m mark. The total time taken to ambulate the central 6 m is recorded to the nearest hundredth of a second. 6 m is then divided by the total time and recorded in m/s (the faster the participant traverses 6 meters the better).
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
10 Meter Walk Test (10MWT) Post-intervention Scores
|
.77 meters per second
Interval 0.67 to 0.88
|
.90 meters per second
Interval 0.78 to 1.03
|
SECONDARY outcome
Timeframe: The pre-assessment 10MWT will be conducted within 48 hours prior to the first study session. The post-assessment 10MWT will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.The 10MWT is used to assess walking speed in meters/second (m/s) over 10 meters (m). The time is started when any part of the leading foot crosses the plane of the 2 m mark. Time is stopped when any part of the leading foot crosses the plane of the 8 m mark. The total time taken to ambulate the central 6 m is recorded to the nearest hundredth of a second. 6 m is then divided by the total time and recorded in m/s (the faster the participant traverses 6 meters the better). The change in 10MWT 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
n=46 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=52 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Difference in 10 Meter Walk Test (10MWT) Pre-Intervention and Post-Intervention Assessment Scores
|
0.1672 meters per second
Interval 0.1046 to 0.2298
|
0.2580 meters per second
Interval 0.1891 to 0.3269
|
SECONDARY outcome
Timeframe: Baseline (within 72 hours of admission).The CARE Item Set and Patient Assessment Instrument measure the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set and Patient Assessment Instrument are designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings.) These two outcomes measure the same concept, but across different healthcare institutions, so a z-score transformation was used. This outcome looked at total mobility score. The Z-score was calculated by taking the raw score, subtracting the population mean of pre- and post-intervention scores, and dividing it by the population standard deviation. A Z-score of 0 represents the population mean. A higher score represents a better score than the mean of the population, and a negative score represents a lower score than the mean of the population.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Pre-Intervention Mobility Admission Z-Scores
|
-.93 Z-score
Interval -1.08 to -0.79
|
-.74 Z-score
Interval -0.89 to -0.74
|
SECONDARY outcome
Timeframe: The post-intervention mobility discharge scores will be collected within 48 hours before discharge from the health system, on average, 17 days.The CARE Item Set and Patient Assessment Instrument measure the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set and Patient Assessment Instrument are designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings.) These two outcomes measure the same concept, but across different healthcare institutions, so a z-score transformation was used. This outcome looked at total mobility score. The Z-score was calculated by taking the raw score, subtracting the population mean of pre- and post-intervention scores, and dividing it by the population standard deviation. A Z-score of 0 represents the population mean. A higher score represents a better score than the mean of the population, and a negative score represents a lower score than the mean of the population.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Post-Intervention Mobility Discharge Z-Scores
|
.76 Z-score
Interval 0.59 to 0.95
|
.91 Z-score
Interval 0.79 to 1.04
|
SECONDARY outcome
Timeframe: Baseline (within 72 hours of admission), and Post-intervention (within 48 hours of discharge from the health system, on average, 17 days).The CARE Item Set and Patient Assessment Instrument measure the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set and Patient Assessment Instrument are designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings.) These two outcomes measure the same concept, but across different healthcare institutions, so a z-score transformation was used. This outcome looked at total mobility score. The Z-score was calculated by taking the raw score, subtracting the population mean of pre- and post-intervention scores, and dividing it by the population standard deviation. A Z-score of 0 represents the population mean. A higher score represents a better score than the mean of the population, and a negative score represents a lower score than the mean of the population.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=49 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Difference in Pre-Intervention and Post-Intervention Mobility Admission and Discharge Z-Scores
|
0.1017 Z-score
Interval -0.2083 to 0.4117
|
-0.05716 Z-score
Interval -0.3133 to 0.1989
|
SECONDARY outcome
Timeframe: Baseline (within 72 hours of admission).The CARE Item Set and Patient Assessment Instrument measure the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set and Patient Assessment Instrument are designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings.) These two outcomes measure the same concept, but across different healthcare institutions, so a z-score transformation was used. This outcome looked at total Self-Care score. The Z-score was calculated by taking the raw score, subtracting the population mean of pre- and post-intervention scores, and dividing it by the population standard deviation. A Z-score of 0 represents the population mean. A higher score represents a better score than the mean of the population, and a negative score represents a lower score than the mean of the population.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Pre-Intervention Self-Care Admission Z-Scores
|
-.90 Z-score
Interval -1.07 to -0.73
|
-.80 Z-score
Interval -0.94 to -0.66
|
SECONDARY outcome
Timeframe: The post-intervention self-care discharge scores will be collected within 48 hours before discharge from the health system, on average, 17 days.The CARE Item Set and Patient Assessment Instrument measure the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set and Patient Assessment Instrument are designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings.) These two outcomes measure the same concept, but across different healthcare institutions, so a z-score transformation was used. This outcome looked at total Self-Care score. The Z-score was calculated by taking the raw score, subtracting the population mean of pre- and post-intervention scores, and dividing it by the population standard deviation. A Z-score of 0 represents the population mean. A higher score represents a better score than the mean of the population, and a negative score represents a lower score than the mean of the population.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=53 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Post-Intervention Self-Care Discharge Z-Scores
|
.80 Z-score
Interval 0.63 to 0.96
|
.90 Z-score
Interval 0.76 to 1.03
|
SECONDARY outcome
Timeframe: Baseline (within 72 hours of admission), and Post-intervention (within 48 hours of discharge from the health system, on average, 17 days).The CARE Item Set and Patient Assessment Instrument measure the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set and Patient Assessment Instrument are designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings.) These two outcomes measure the same concept, but across different healthcare institutions, so a z-score transformation was used. This outcome looked at total Self-Care score. The Z-score was calculated by taking the raw score, subtracting the population mean of pre- and post-intervention scores, and dividing it by the population standard deviation. A Z-score of 0 represents the population mean. A higher score represents a better score than the mean of the population, and a negative score represents a lower score than the mean of the population.
Outcome measures
| Measure |
Body Weight Support System Control Group
n=47 Participants
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Body weight support system control group: Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
|
Body Weight Support System With Balance Perturbations
n=49 Participants
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises 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. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Body weight support system with balance perturbations: Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,
|
|---|---|---|
|
Difference in Pre-Intervention and Post-Intervention Self-Care Admission and Discharge Z-Scores
|
0.03366 Z-score
Interval -0.2783 to 0.3456
|
0.009921 Z-score
Interval -0.2482 to 0.268
|
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: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place