Reactive Standing Balance Step Training Post Stroke

NCT05772936 | Completed

• 1 other identifier: RST4CVA2018
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effectiveness of reactive step training on the timing and frequency of perturbation induced paretic leg stepping in persons post stroke. The study will consist of one or six one-hour training sessions and a pre and post visit each lasting up to two hours at our downtown Chicago location.

Conditions

Stroke, Cerebrovascular

Outcome Measures

Primary Outcomes (3)

• Change in frequency of stepping with paretic leg after a perturbation

  number of trials when the paretic leg takes the first reactive step after the perturbation is applied during the reactive trials.

  Change in stepping with paretic leg will be modeled from baseline and immediately after the intervention.

• Change in step onset time for voluntary and reactive steps

  step onset time is the time the stepping foot lifts off the ground after the Go cue for voluntary steps and after the perturbation for the reactive steps.

  Change in step onset will be modeled from baseline and immediately after the intervention.

• Change in reactive lean balance test

  Lean balance test is a passive way to test reactive stepping. Participants will lean again the research staff hands until their center of mass is at the edge of their feet. The research staff will suddenly remove their hands and allow the participant to catch their balance. Research staff are trained to perform the test and to guard the participant if needed. Extra personnel will be near by for additional support if the participant is not able to recover their balance.

  Change in reactive lean balance test will be modeled from baseline and immediately after the intervention.

Secondary Outcomes (2)

• 10 meter walk test

  Day 1 before training

• Activities-specific Balance Confidence scale (ABC)

  Day 1 before training

Study Arms (1)

single arm non-randomized

EXPERIMENTAL

all enrolled subjects will participate in the perturbation-induced step training, 1 or 6 sessions about 1-1.5 hour (30-90 trials) each session.

Behavioral: Balance training

Interventions

Balance training BEHAVIORAL

perturbation induce step training to improve reactive stepping with paretic leg.

single arm non-randomized

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 1 year post a single unilateral hemispheric stroke (CVA)
• living independently in the community
• able to walk 25 feet without assistive device

You may not qualify if:

• pain that limits movement
• joint surgery of the lower extremity
• unable to give consent
• significant postural alignment deficits such as scoliosis or genu recurvatum
• loss of sensation in the lower limb

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Katherine M Martinez, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: March 17, 2023
• Study Start: January 22, 2019
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available 6 months after publication
• Access Criteria: access to data will be made available by contacting the principle investigator.

Locations

US (1)