Lateral Perturbation Induced Step Training Compared to Lateral Voluntary Step Training in People with Chronic Stroke

NCT ID: NCT06638476

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2018-03-30

Brief Summary

The goal of this clinical trial is to see if perturbation-induced step training improves stepping performance during a reactive and voluntary step. The main questions it aims to answer are:

Does perturbation induced step training improve step initation time and first recovery step?

Researchers will compare lateral perturbation induced step training to lateral voluntary step training to see if the first recovery steps improve.

Participants will:

Vist the lab for an initial assessment, post exercise and one month post exercise of voluntary and perturbation induced stepping performance, and clinical tests of balance, motor recovery, sensory and strength tests.

Exercise 3 times a week for 6 weeks in person

Track falls for 6 months after the exercise.

Detailed Description

Stroke is the leading cause of disability in the United States as the result of an increased survival rate over the last 25 years. A high frequency of falls is commonly reported in this group due to the residual sensorimotor deficits and impairments to balance. Many falls occur when weight is transferred laterally and an equal number of falls happen during voluntary movements as during unexpected disturbances such as a trip, push or pull. Typically, either will involve a protective step to recover balance. Thus, the purpose of this study is to compare the effects of reactive lateral step training to voluntary lateral step training on the performance of the protective step, functional balance and falls in persons post-stroke. Thirty participants with a stroke will be randomized to one of two interventions, reactive step training or voluntary step training. In the voluntary step training group, participants will perform voluntary steps. In the reactive step training group, participants will perform reactive steps generated by the Active Step. The training will be 3 times a week for 6 weeks. The step initiation time, will be compared in both the voluntary and reactive steps at baseline before the intervention, post-intervention and a test of retention will occur one month after the training. Functional balance will be assessed with the Community Balance & Mobility Scale and falls will be compared in the 6 months preceding the intervention to 6 months post-intervention testing. If reactive step training is effective, then the protective step characteristics, functional balance and the number of falls will be reduced compared to the voluntary step training group.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perturbation induced step training

Participants will receive 18 sessions over 6 weeks.

Group Type: EXPERIMENTAL

Perturbation Induced Step training

Intervention Type: OTHER

A sudden lateral displacement of the treadmill.

Voluntary Step training

Participants will receive 18 sessions over 6 weeks.

Group Type: ACTIVE_COMPARATOR

Voluntary step training

Intervention Type: OTHER

Voluntary steps emphasizing speed, movement of center of mass and taking larger steps.

Interventions

Perturbation Induced Step training

A sudden lateral displacement of the treadmill.

Intervention Type: OTHER

Voluntary step training

Voluntary steps emphasizing speed, movement of center of mass and taking larger steps.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Hemiparesis as a result of a stroke greater than 6 months previous to the study
• Able to walk 10 meters with or without a walking aid
• Have the cognitive ability to give informed consent

Exclusion Criteria

• Medical condition precluding participation in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies.
• Bilateral stroke or a previous stroke in the contralateral hemisphere.
• Aphasia

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vicki Gray

OTHER

Sponsor Role: lead

Responsible Party

Vicki Gray

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Maryland Baltimore

Baltimore, MD, Maryland, United States

Countries

United States

Other Identifiers

American Heart Association

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H133P100014, H133F140027

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P30AG028747

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00056550

Identifier Type: -

Identifier Source: org_study_id