Health TrialsbyHealthPanel

MINT Conditioning to Improve Gait

ConditionsStrokeStroke Gait Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNorthwestern University

About this trial

This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at enrollment is 18 to 85

Leg impairment from unilateral stroke at least 6 months prior to screening

Severe to moderate gait impairment (ambulatory with a maximum walking speed of 0.8 m/s, i.e., half of normal speed)

Able to stand without assistance

Disqualifiers

Cognitive impairment with at least moderately impaired attention on digit-span test, or unable to follow instructions of the MINT task

Visual impairment (such as hemianopia) preventing sufficient perception of the screen to play the games

Anesthesia or severe neglect in the affected leg, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest) that impairs ability to play the games

Participation in another study on the affected leg, or any pharmacological study, within 6 weeks of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • myoelectric interface for neurorehabilitation (MINT) conditioning

    Other intervention

    Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.

  • One muscle myoelectric feedback

    Other intervention

    Training to control muscle activity in one muscle only.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: MINT groupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

10-m walk test

The 10-m walk test measures gait speed

Time frame
Baseline and 4 weeks

Secondary outcomes

1

6-min walk test

The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.

Time frame
Baseline and week 4
2

10-m walk test

The 10-m walk test measures gait speed

Time frame
Baseline and week 8
3

6-min walk test

The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.

Time frame
Baseline and week 8
4

MINT performance

The mean weighted time-to-target over trials.

Time frame
each training session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

University of Texas Southwestern Medical Center

Collaborator

Source ClinicalTrials.gov
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