search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Stroke Subjects Perturbation-Based Balance Training
Stroke Subjects Weight Shifting and Gait training
Sponsored by
Nachum Soroker, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loewenstein hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Perturbation-based balance training

Weight shifting and gait training

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Compensatory Step Execution Time
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.
Change in Compensatory Step Velocity
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

Change in Berg Balance Scale Score
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.
Change in Fall Threshold
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.
Change in Activities-specific Balance Confidence (ABC) Scale
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.

Full Information

First Posted
November 23, 2015
Last Updated
September 2, 2019
Sponsor
Nachum Soroker, MD
Collaborators
Ben-Gurion University of the Negev
search

1. Study Identification

Unique Protocol Identification Number
NCT02619175
Brief Title
Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
Official Title
Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nachum Soroker, MD
Collaborators
Ben-Gurion University of the Negev

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perturbation-based balance training
Arm Type
Experimental
Arm 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.
Arm Title
Weight shifting and gait training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Stroke Subjects Perturbation-Based Balance Training
Intervention Type
Device
Intervention Name(s)
Stroke Subjects Weight Shifting and Gait training
Primary Outcome Measure Information:
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.
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.
Secondary Outcome Measure Information:
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.
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nachum Soroker
Organizational Affiliation
Loewenstein rehabilitation hospital, Raanana, ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loewenstein hospital
City
Raanana
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
34369447
Citation
Handelzalts S, Steinberg-Henn F, Farquhar J, Shkedy Rabani A, Levy S, Riemer R, Soroker N, Melzer I. Temporal But Not Spatial Gait Parameters Associated With Lower Balance Capacity in Moderate-High Functioning Persons With Stroke. J Neurol Phys Ther. 2021 Oct 1;45(4):301-309. doi: 10.1097/NPT.0000000000000368.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs