Trial Outcomes & Findings for Gait Training Combined With Behavioral Strategies for People With Stroke (NCT NCT04546217)

Last Updated: 2024-05-22

Results Overview

It is a semi-structured interview that consists of questions asking the participant the level of assistance, how well her/his performance is, and level of confidence while executing 14 different daily tasks (e.g. walking indoors, climbing stairs) in real world environment. The LE-MAL investigates the transference of the skills addressed during the treatment to different contexts. The LE-MAL is a reliable tool in both test-retest results (r=0.93) and internal consistency (Cronbach's alpha = 0.96). The score range from 0-10, where 0 is a higher level of assistance, worse quality and movement and less confidence, and 10 is given when no assistance is needed, good quality of movement is reported and the person feels completely confident in performing the activity without falling.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.

Results posted on

2024-05-22

Participant Flow

The recruitment was delayed due to the SARS-COVID pandemic. Thus, instead of the initial 24 participants, a 2:1 ratio was used targeting to enroll at least 18 individuals. This way, from the total 19 individuals included in this study, 12 were assigned to the TT+TP and 7 to the TT. Participants were recruited from a list of patients from the Spain Rehabilitation Center at UAB or were referred by UAB physicians and therapists. Recruitment were conducted from October 2020 to April 2022.

The of the study started during the SARS-COVID pandemic, leading to challenges on recruitment, scheduling due to institutional and individual restrictions. Considering that the study participants were considered at high risk to develop severe symptoms if contracted the virus, the first participant started 8 months after was predicted, and the number of participants needed to be reduced to accommodate institutional restrictions and follow the timeline provided by the funding source.

Participant milestones

Participant milestones
Measure	Treadmill Training +Transfer Package (TT+TP) The TT+TP group received 18 1.5h sessions (3x for 6 weeks) of robotic treadmill (KineAssist) gait training. In combination with the gait training, participants in this group received the "Transfer Package" (TP). On each session, 1h was allocated for the gait training and 30 minutes for the TP. As part of the TP, participants signed a behavioral contract to achieve safety while engaging in activities outside the clinic, increase use of their paretic leg in daily activities, and increase coordination of both legs. The TP also included a list of activities to be performed outside the clinical setting, the Home Skill Assignment, that was developed daily during the treatment period and given to the participants at the end of the session. There were also the Home Practice after treatment to assure continued progress with LE use after the intervention program is completed. The Lower Extremity Motor Activity Log (LE-MAL) was administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of of confidence that their are able to maintain their balance during activity performance. Participants were assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. confidence.	Treadmill Training (TT) The TT group will receive 18 sessions (3x week for 6 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
Overall Study STARTED	12	7
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treadmill Training +Transfer Package (TT+TP) The TT+TP group received 18 1.5h sessions (3x for 6 weeks) of robotic treadmill (KineAssist) gait training. In combination with the gait training, participants in this group received the "Transfer Package" (TP). On each session, 1h was allocated for the gait training and 30 minutes for the TP. As part of the TP, participants signed a behavioral contract to achieve safety while engaging in activities outside the clinic, increase use of their paretic leg in daily activities, and increase coordination of both legs. The TP also included a list of activities to be performed outside the clinical setting, the Home Skill Assignment, that was developed daily during the treatment period and given to the participants at the end of the session. There were also the Home Practice after treatment to assure continued progress with LE use after the intervention program is completed. The Lower Extremity Motor Activity Log (LE-MAL) was administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of of confidence that their are able to maintain their balance during activity performance. Participants were assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. confidence.	Treadmill Training (TT) The TT group will receive 18 sessions (3x week for 6 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
Overall Study Withdrawal by Subject	2	0
Overall Study Uncontrolled hypertension	1	0

Baseline Characteristics

Gait Training Combined With Behavioral Strategies for People With Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treadmill Training +Transfer Package (TT+TP) n=12 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the transfer package. Treadmill training + transfer package (TT+TP): Participants will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. In combination with the gait training, participants will also receive a group of behavioral strategies (Transfer Package). Participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence.	Treadmill Training (TT) n=7 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.	Total n=19 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	53.1 years n=7 Participants	51.2 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	7 participants n=7 Participants	19 participants n=5 Participants
NeuroQOL - Quality of Life in Neurological Disorders	28 units on a scale STANDARD_DEVIATION 5.6 • n=5 Participants	26.9 units on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	27.6 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants
Time since stroke	2.0 years n=5 Participants	2.6 years n=7 Participants	2.2 years n=5 Participants
Affected side Left side	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Affected side Right side	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.

Population: COVID affected the duration of the program, which changed from 8 to 6 weeks. Overall, 5 out of 19 individuals were excluded or withdrawn. From those, 1 from the TT group completed the training sessions, but could not progress on the training, receiving 18 sessions of only endurance training instead of 6 sessions of each endurance, strengthening, and speed training. From the TT+TP group, 4 were exclude: 1 for transportation issues, 2 were not available, and 1 due to uncontrolled hypertension.

Outcome measures

Outcome measures
Measure	Treadmill Training +Transfer Package (TT+TP) n=8 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the TP. As part of the TP, participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence. Participants will be assessed pre-, post-intervention, 3 and 6 months after the intervention.	Treadmill Training (TT) n=6 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities. Total score Pre-treatment	6.3 score on a scale Standard Deviation 1.11	6.4 score on a scale Standard Deviation 1.11
Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities. Total score Post-treatment	7.3 score on a scale Standard Deviation 1.02	7.2 score on a scale Standard Deviation 0.82
Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities. Total score 3 months Follow up	7.4 score on a scale Standard Deviation 1.16	7.5 score on a scale Standard Deviation 0.65
Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities. Total score 6 months Follow up	7.8 score on a scale Standard Deviation 1.10	7.5 score on a scale Standard Deviation 0.74

PRIMARY outcome

It is a valid and reliable tool to assess balance control in both static and dynamic activities with people with different health conditions. The Berg includes 14 balance tasks, each one scored from 0 (inability to perform or need for maximum assistance) to 4 (able to perform the task without difficulty or independently). The total score range from 0-56 and a score lower than 44 represents high risk of falling.

Outcome measures

Outcome measures
Measure	Treadmill Training +Transfer Package (TT+TP) n=8 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the TP. As part of the TP, participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence. Participants will be assessed pre-, post-intervention, 3 and 6 months after the intervention.	Treadmill Training (TT) n=6 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
Berg Balance Scale - Balance Assessment Pre-treatment	44.8 score on a scale Standard Deviation 5.52	47.5 score on a scale Standard Deviation 3.69
Berg Balance Scale - Balance Assessment Post-treatment	46.4 score on a scale Standard Deviation 5.17	50.2 score on a scale Standard Deviation 3.62
Berg Balance Scale - Balance Assessment 3 months follow-up	46.3 score on a scale Standard Deviation 4.2	50.0 score on a scale Standard Deviation 3.51
Berg Balance Scale - Balance Assessment 6 months follow-up	44.8 score on a scale Standard Deviation 5.76	48.8 score on a scale Standard Deviation 3.62

PRIMARY outcome

It is a gait speed measurement, which is an easy and reliable assessment of locomotion. In this assessment, the individual is asked to walk 10 meter, with or without an assistive decide, and the speed is calculated according to the time the individual takes from the beginning to the end of the 10 meter trail. During the self-selected speed, the individual is asked to walk at his/her/their normal speed, as if the person is walking at home. On the fast speed, the individual is asked to speed up and walk fast as he/she/they can, but not running.

Outcome measures

Outcome measures
Measure	Treadmill Training +Transfer Package (TT+TP) n=8 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the TP. As part of the TP, participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence. Participants will be assessed pre-, post-intervention, 3 and 6 months after the intervention.	Treadmill Training (TT) n=6 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
10 Meters Walk Test - Walking Speed Assessment Self-selected speed pre-treatment	0.42 meters/second Standard Deviation 0.16	0.46 meters/second Standard Deviation 0.21
10 Meters Walk Test - Walking Speed Assessment Self-selected speed post-treatment	0.46 meters/second Standard Deviation 0.19	0.50 meters/second Standard Deviation 0.20
10 Meters Walk Test - Walking Speed Assessment Self-selected speed 3-month follow-up	0.53 meters/second Standard Deviation 0.23	0.59 meters/second Standard Deviation 0.26
10 Meters Walk Test - Walking Speed Assessment Self-selected speed 6-month follow-up	0.52 meters/second Standard Deviation 0.25	0.65 meters/second Standard Deviation 0.28
10 Meters Walk Test - Walking Speed Assessment Fast speed pre-treatment	0.56 meters/second Standard Deviation 0.27	0.59 meters/second Standard Deviation 0.26
10 Meters Walk Test - Walking Speed Assessment Fast speed post-treatment	0.60 meters/second Standard Deviation 0.29	0.64 meters/second Standard Deviation 0.30
10 Meters Walk Test - Walking Speed Assessment Fast speed 3-month follow-up	0.70 meters/second Standard Deviation 0.34	0.76 meters/second Standard Deviation 0.34
10 Meters Walk Test - Walking Speed Assessment Fast speed 6-month follow-up	0.66 meters/second Standard Deviation 0.35	0.74 meters/second Standard Deviation 0.32

SECONDARY outcome

Population: COVID has impacted the duration of the treatment that changed from 8 to 6 weeks. Two individuals from TT group were not able to complete this test in one or more of the assessments visits, therefore, for this test, just 4 out of 6 individuals were included in the analysis. Four individuals of the TT+TP group were not able to complete this test in one or more of the assessments visits, therefore, for this test, just 4 out of 8 individuals were included in the analysis.

Functional strength assessment tool. In this assessment, the individual is asked to stand up and sit on a chair 5 times and the time spend to perform the task is recorded. A performance time longer than 12 seconds is considered abnormal.

Outcome measures

Outcome measures
Measure	Treadmill Training +Transfer Package (TT+TP) n=4 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the TP. As part of the TP, participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence. Participants will be assessed pre-, post-intervention, 3 and 6 months after the intervention.	Treadmill Training (TT) n=4 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
5-times-sit-to-stand - Functional Strength Assessment Pre-treatment	18.3 Seconds Standard Deviation 2.59	20.3 Seconds Standard Deviation 4.2
5-times-sit-to-stand - Functional Strength Assessment Post-treatment	17.2 Seconds Standard Deviation 1.70	18.0 Seconds Standard Deviation 3.74
5-times-sit-to-stand - Functional Strength Assessment 3-month Follow-up	17.0 Seconds Standard Deviation 1.80	17.0 Seconds Standard Deviation 4.79
5-times-sit-to-stand - Functional Strength Assessment 6-month Follow-up	14.7 Seconds Standard Deviation 1.31	14.7 Seconds Standard Deviation 3.88

SECONDARY outcome

It is a tool to assess energy expenditure and endurance during walking. The total distance in meters that the individual walked in a 6 minutes period is recorded.

Outcome measures

Outcome measures
Measure	Treadmill Training +Transfer Package (TT+TP) n=8 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the TP. As part of the TP, participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence. Participants will be assessed pre-, post-intervention, 3 and 6 months after the intervention.	Treadmill Training (TT) n=6 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
6-minutes Walking Test - Energy Expenditure Assessment. Pre-treatment	147.1 Meters Standard Deviation 70.05	168.2 Meters Standard Deviation 72.67
6-minutes Walking Test - Energy Expenditure Assessment. Post-treatment	170.5 Meters Standard Deviation 71.89	184.5 Meters Standard Deviation 81.05
6-minutes Walking Test - Energy Expenditure Assessment. 3-month Follow-up	191.2 Meters Standard Deviation 77.88	212.4 Meters Standard Deviation 92.27
6-minutes Walking Test - Energy Expenditure Assessment. 6-month Follow-up	185.9 Meters Standard Deviation 82.48	223.8 Meters Standard Deviation 107.57

SECONDARY outcome

In this assessment, the individuals are asked about activities that they avoid due to their fear of falling. It is a questionnaire that identifies how the fear of falling has affected the performance of 14 activities scored from 0 to 4 where 0 means "I completely disagree that I avoid this activity because I am afraid of falling", and 4 means "I completely agree that I avoid this activity because I am afraid of falling". The total score ranges from 0 to 56 where higher scores indicate higher number of activities avoided due to their fear of falling.

Outcome measures

Outcome measures
Measure	Treadmill Training +Transfer Package (TT+TP) n=8 Participants The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the TP. As part of the TP, participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence. Participants will be assessed pre-, post-intervention, 3 and 6 months after the intervention.	Treadmill Training (TT) n=6 Participants The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change. Treadmill training (TT): Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment Pre-treatment	16.3 units on a scale Standard Deviation 9.87	14.0 units on a scale Standard Deviation 9.00
Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment Post-treatment	16.0 units on a scale Standard Deviation 8.87	12.8 units on a scale Standard Deviation 6.77
Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment 3-month Follow up	16.1 units on a scale Standard Deviation 5.58	16.3 units on a scale Standard Deviation 5.85
Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment 6-month Follow up	14.1 units on a scale Standard Deviation 6.23	13.2 units on a scale Standard Deviation 4.56

Adverse Events

Treadmill Training +Transfer Package (TT+TP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treadmill Training (TT)

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

Dr. Sarah dos Anjos

University of Alabama at Birmingham

Phone: 2059347323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place