Machines Assisting Recovery From Stroke

NCT02787694 | Completed Results

• 1 other identifier: F130305002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Locomotor disability remains a major obstacle to community function in stroke survivors. This disability is best characterized by the reduced gait speed and enhanced risk of falls that is observed in the majority of stroke survivors. Current robotic systems have focused on repetitive stepping in constrained, less-challenging environments than overground training and have failed to produce results that can justify their use. In contrast to this approach, this study will use a combinatorial approach on a moving platform (KineAssist-Mobility Activity Center) that simulates and enhances the challenges of overground training. We focus on five critical factors that contribute to reduced speed and fall risk during mobility activities: 1) lower limb weakness; 2) slow lower limb movements; 3) reduced balance; 4) reduced ability to respond to challenges during walking; and 5) reduced aerobic capacity. The end product of this study is to develop a comprehensive and standardized system for assessing and prescribing specific training modalities that can be used by clinicians to help stroke survivors who are limited by slow walking speed and high fall risk, and can improve participation in mobility activities.

Conditions

Cerebrovascular Disease; Sequelae

Keywords

stroke; walking; balance; exercise

Outcome Measures

Primary Outcomes (1)

• 10 m Walk Test

  Overground 10 meter walk test consisting of three trials administered at baseline (pre-intervention) and at 10 weeks (post-intervention).

  Baseline (pre-intervention) and 10 weeks (post-intervention)

Study Arms (1)

Factor Targeted Walking Training

EXPERIMENTAL

Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results

Other: Factor Targeted Walking Training; Device: treadmill

Interventions

Factor Targeted Walking Training OTHER

Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches

Factor Targeted Walking Training

treadmill DEVICE

Factor Targeted Walking Training

Eligibility Criteria

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

You may qualify if:

• Community dwelling unilateral stroke survivors, aged 19 years or older, at least 4 months post incident, residual hemiplegia, who are able to ambulate at least 14m with an assistive device or the assistance of one person, with receptive and expressive communication capability, approval of physician, and voluntarily provided informed consent.

You may not qualify if:

• Significant and acute medical conditions, amputations, spasticity management that included phenol block injections within 12 months or botulinum toxin injections within 4 months of the study, any cognition involvement that impairs the ability to follow directions for, and plans to move out of the area within the next year or no transportation to the study area.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Locomotor Control Lab

Birmingham, Alabama, 35210, United States

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke; Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Results Point of Contact

• Title: David A. Brown, PT, PhD
• Organization: University of Alabama at Birmingham

dbrownpt@uab.edu

205-975-2788

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 2, 2019
• Results First Posted: March 25, 2019

Record last verified: 2019-03

Locations

US (1)