Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals

• Sponsor: Nachum Soroker, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02619175
• Collaborator: Ben-Gurion University of the Negev (Other)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Stroke Subjects Perturbation-Based Balance Training; Device: Stroke Subjects Weight Shifting and Gait training	Early Phase 1

Detailed Description

60 stroke subjects from the neurology rehabilitation unit at Loewenstein hospital will be randomly allocated to one of two groups: 1) perturbations based balance training 2) weight shifting and gait training without external perturbations (control).

Group 1 - Perturbations based balance training Subjects will complete a perturbation based balance training while standing and walking on the BalanceTutor (MediTouch). Perturbation level will be individually adjusted and progressed according to subject's abilities. Progression occurs by increasing perturbation level (increase distance, velocity and acceleration). At each practiced level subjects will be exposed to random right/left/forward/backward unannounced platform translations while standing and to right/left perturbations (in defined events in gait cycle) while walking. In order to examine adaptation to repeated perturbations, kinematic data will be collected in the first session.

Group 2 - Weight shifting and gait training Subjects will complete a balance training program that includes voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. Weight shifting toward a target will be adjusted and progressed according to subject's abilities. Progression in difficulty level will occur by increasing the distance to target without changing the base of support. At each practiced level weight shifting will be conducted to right/left/forward/backward directions. In the gait part of the session, subjects will be asked to walk at their preferred treadmill walking speed.

Subjects in both groups will complete 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes and will include practice in standing and walking. Subject's activities will be documented in each session in both groups. Furthermore, in each session subjects will be asked to rate their perceived level of challenge on a 0-10 scale.

Pre- and post-intervention measurements will be conducted. A follow-up measurement will be conducted 3-6 weeks post intervention.

The following measurements will be administered:

1)Compensatory balance reaction kinematic measurement:

Compensatory balance reactions will be measured using the BalanceTutor (MediTouch). The BalanceTutor is a mechatronic device consisting of a computerized treadmill with a horizontal movable platform and an operator station. Measurements will be taken in two conditions:

Standing. Subjects will be instructed to stand and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled. The increases in platform translation will be adjusted by the examiner to the subject's ability to recover from perturbations. Participants will be asked to respond in a "natural" manner to perturbations.

Walking. Subjects will be instructed to walk comfortably (self-paced) on the treadmill, and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled and will be adjusted by the examiner to the subject's ability to recover from perturbations. Compensatory balance reaction characteristics (reaction time, swing time, compensatory step time, step length etc.) will be collected through a three-dimensional motion analysis system. During examination subjects will wear a loose safety harness that will prevent a fall and yet allow the execution of balance recovery reactions.

In addition, clinical measures will be used: Berg Balance Scale, 6 minute walk test, 10 meter walk test, the Fugl-Meyer test for motor recovery after stroke and the ABC (Activities-specific Balance Confidence) scale. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: RCTRCT
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perturbation-based balance training 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.	Device: Stroke Subjects Perturbation-Based Balance Training
Active Comparator: Weight shifting and gait training 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.	Device: Stroke Subjects Weight Shifting and Gait training

Outcome Measures

Primary Outcome Measures

1. Change in Compensatory Step Execution Time [1-5 days before the first session of intervention and 1-5 days after the last session of intervention.]

   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.

2. Change in Compensatory Step Velocity [1-3 days before the first session of intervention and 1-3 days after the last session of intervention.]

   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.

Secondary Outcome Measures

1. Change in Berg Balance Scale Score [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.

2. Change in Fall Threshold [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.

3. Change in Activities-specific Balance Confidence (ABC) Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

For measurements taken while standing, post stroke subjects will meet the criteria of being able to stand independently or with supervision for at least 2 minutes.

For measurements taken while walking, post stroke subjects will meet the criteria of being able to walk for at least 10 meter with supervision/independently without walking aids.

• 3 weeks-6 months post stroke (hemorrhage/infarct)

• First stroke

• Age 25-75 years

• Able to understand research instructions

• Stable clinical/metabolic state

Exclusion Criteria:

• • A history of neurological diseases amongst peripheral neuropathy

• Significant skeletal system diseases, such as severe osteoporosis

• Uncontrolled atrial fibrillation

• Unstable ischemic heart disease

• Significant visual deficiency

• Dizziness

• Pregnancy

• Body weight above 135 kg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loewenstein hospital	Raanana		Israel

Sponsors and Collaborators

• Nachum Soroker, MD
• Ben-Gurion University of the Negev

Investigators

• Principal Investigator: nachum Soroker, Loewenstein rehabilitation hospital, Raanana, ISRAEL

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 2, 2019

More Information

Publications

None provided.

• Responsible Party: Nachum Soroker, MD, head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel, Loewenstein Hospital
• ClinicalTrials.gov Identifier: NCT02619175
• Other Study ID Numbers: loe150021ctil
• First Posted: Dec 2, 2015
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Perturbation-based Balance Training, Stroke Subjects	Weight Shifting and Gait Training, Stroke Subjects
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	18	16
COMPLETED	16	16
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Perturbation-based Balance Training	Weight Shifting and Gait Training	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	18	16	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (8.7)	60.4 (10.1)	61.4 (9.2)
Sex: Female, Male (Count of Participants)
Female	4 22.2%	4 25%	8 23.5%
Male	14 77.8%	12 75%	26 76.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Days post stroke (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	40.6 (17.0)	43.7 (19.7)	42.0 (18.7)

Outcome Measures

1. Primary Outcome

Title	Change in Compensatory Step Execution Time
Description	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.
Time Frame	1-5 days before the first session of intervention and 1-5 days after the last session of intervention.

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Perturbation-based Balance Training	Weight Shifting and Gait Training
Arm/Group Description	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	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
Measure Participants	13	8
Mean (Standard Deviation) [msec]	-119.7 (236.6)	-4.2 (44.4)

2. Primary Outcome

Title	Change in Compensatory Step Velocity
Description	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.
Time Frame	1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Perturbation Based Balance Training	Weight-shifting and Gait Training
Arm/Group Description	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	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
Measure Participants	13	8
Mean (Standard Deviation) [m/sec]	0.05 (0.2)	-0.05 (0.08)

3. Secondary Outcome

Title	Change in Berg Balance Scale Score
Description	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.
Time Frame	1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Perturbation-based Balance Training, Stroke Subjects	Weight Shifting and Gait Training, Stroke Subjects
Arm/Group Description	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	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
Measure Participants	16	16
Mean (Standard Deviation) [units on a scale 0-56.]	5.7 (3.9)	5.8 (5.6)

4. Secondary Outcome

Title	Change in Fall Threshold
Description	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.
Time Frame	1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Perturbation Based Balance Training	Weight Shifting and Gait Training
Arm/Group Description	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	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
Measure Participants	16	16
Mean (Standard Deviation) [score on a scale]	1.93 (1.6)	1.12 (1.8)

5. Secondary Outcome

Title	Change in Activities-specific Balance Confidence (ABC) Scale
Description	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.
Time Frame	1-3 days before the first session of intervention and 1-3 days after the last session of intervention.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Perturbation-based Balance Training	Weight Shifting and Gait Training
Arm/Group Description	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	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
Measure Participants	16	16
Mean (Standard Deviation) [score on a scale]	17.9 (16.01)	4.1 (9.23)

Adverse Events

Time Frame	from pre-intervention assessment until post-intervention assessment (1 month)
Arm/Group Title	BalanceTutor		Posturograph
Arm/Group Description	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		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
All Cause Mortality
	BalanceTutor		Posturograph
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Serious Adverse Events
	BalanceTutor		Posturograph
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	BalanceTutor		Posturograph
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)		0/16 (0%)
Musculoskeletal and connective tissue disorders
foot pain	1/18 (5.6%)	1	0/16 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.