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

NCT02619175 | Completed Early Phase 1 Results

• 1 other identifier: loe150021ctil
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (3)

• 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.

• Change in Fall Threshold

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

• 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.

Study Arms (2)

Perturbation-based balance training

EXPERIMENTAL

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

Weight shifting and gait training

ACTIVE COMPARATOR

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

Interventions

Stroke Subjects Perturbation-Based Balance Training DEVICE

Perturbation-based balance training

Stroke Subjects Weight Shifting and Gait training DEVICE

Weight shifting and gait training

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• weeks-6 months post stroke (hemorrhage/infarct)
• First stroke
• Age 25-75 years
• Able to understand research instructions
• Stable clinical/metabolic state

You may not qualify if:

• \- 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

Sponsors & Collaborators

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

Study Sites (1)

Loewenstein hospital

Raanana, Israel

Location

Related Publications (1)

• 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.

  PMID: 34369447 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Mrs. Shirley Handelzalts
• Organization: Loewenstein Rehabilitation Hospital

peregshir@gmail.com

972-9-7709010

Study Officials

• nachum Soroker

  Loewenstein rehabilitation hospital, Raanana, ISRAEL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel

Model Details: RCT

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 2, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

IL (1)