Trial Outcomes & Findings for Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals (NCT NCT02619175)

Results Overview

Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system. Step execution time in response to surface translations toward the non-paretic side.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

34 participants

Primary outcome timeframe

1-5 days before the first session of intervention and 1-5 days after the last session of intervention.

Results posted on

2019-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Perturbation-based Balance Training, Stroke Subjects perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training, Stroke Subjects Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Overall Study STARTED	18	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Perturbation-based Balance Training, Stroke Subjects perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training, Stroke Subjects Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Overall Study Withdrawal by Subject	1	0
Overall Study foot pain	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perturbation-based Balance Training n=18 Participants perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training n=16 Participants Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph	Total n=34 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 8.7 • n=18 Participants	60.4 years STANDARD_DEVIATION 10.1 • n=16 Participants	61.4 years STANDARD_DEVIATION 9.2 • n=34 Participants
Sex: Female, Male Female	4 Participants n=18 Participants	4 Participants n=16 Participants	8 Participants n=34 Participants
Sex: Female, Male Male	14 Participants n=18 Participants	12 Participants n=16 Participants	26 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Days post stroke	40.6 days STANDARD_DEVIATION 17.0 • n=18 Participants	43.7 days STANDARD_DEVIATION 19.7 • n=16 Participants	42.0 days STANDARD_DEVIATION 18.7 • n=34 Participants

PRIMARY outcome

Timeframe: 1-5 days before the first session of intervention and 1-5 days after the last session of intervention.

Population: Analysis was conducted for step responses at perturbation level 3, since step responses were not frequently induced at low perturbation intensities and most subjects were not able to recover balance loss at higher perturbation intensities. Data represent subjects who reached intensity 3 without a fall in previous intensities (n=13 and n=8).

Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system. Step execution time in response to surface translations toward the non-paretic side.

Outcome measures

Outcome measures
Measure	Perturbation-based Balance Training n=13 Participants perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training n=8 Participants Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Change in Compensatory Step Execution Time	-119.7 msec Standard Deviation 236.6	-4.2 msec Standard Deviation 44.4

PRIMARY outcome

Timeframe: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

Population: Analysis was conducted for step responses at perturbation level 3, since step responses were not frequently induced at low perturbation intensities and most subjects were not able to recover balance loss at higher perturbation intensities. Data represent subjects who reached intensity 3 without a fall in previous intensities (n=13 and n=8).

will be calculated from step length and step swing time data, using a 3D motion analysis system. Step velocity in response to surface translations toward the non-paretic side.

Outcome measures

Outcome measures
Measure	Perturbation-based Balance Training n=13 Participants perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training n=8 Participants Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Change in Compensatory Step Velocity	0.05 m/sec Standard Deviation 0.2	-0.05 m/sec Standard Deviation 0.08

SECONDARY outcome

Timeframe: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

A 14-item objective measure (ordinal scale) designed to assess static balance and fall risk. Minimus score =0, Maximal score=56. Higher values represent a better outcome.

Outcome measures

Outcome measures
Measure	Perturbation-based Balance Training n=16 Participants perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training n=16 Participants Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Change in Berg Balance Scale Score	5.7 units on a scale 0-56. Standard Deviation 3.9	5.8 units on a scale 0-56. Standard Deviation 5.6

SECONDARY outcome

Timeframe: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

The perturbation level at which the subject lost balance and fell into the safety harness. Score on a scale (1-7). Each unit represents the perturbation intensity where the subject was unable to recover balance and fell into harness system. Higher values represent a better outcome.

Outcome measures

Outcome measures
Measure	Perturbation-based Balance Training n=16 Participants perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training n=16 Participants Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Change in Fall Threshold	1.93 score on a scale Standard Deviation 1.6	1.12 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Score on a scale (0-100). Higher values represent a better outcome.

Outcome measures

Outcome measures
Measure	Perturbation-based Balance Training n=16 Participants perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Weight Shifting and Gait Training n=16 Participants Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Change in Activities-specific Balance Confidence (ABC) Scale	17.9 score on a scale Standard Deviation 16.01	4.1 score on a scale Standard Deviation 9.23

Adverse Events

BalanceTutor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Posturograph

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BalanceTutor n=18 participants at risk perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. BalanceTutor	Posturograph n=16 participants at risk Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. posturograph
Musculoskeletal and connective tissue disorders foot pain	5.6% 1/18 • Number of events 1 • from pre-intervention assessment until post-intervention assessment (1 month)	0.00% 0/16 • from pre-intervention assessment until post-intervention assessment (1 month)

Additional Information

Mrs. Shirley Handelzalts

Loewenstein Rehabilitation Hospital

Phone: 972-9-7709010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place