Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: task-practice therapy; Other: Vibration

• Registration Number: NCT03473808
• Lead Sponsor: Medical University of South Carolina

Brief Summary

After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.

Detailed Description

The ability to predict individuals' responses to treatment can enable effective allocation of a treatment to likely responders. The long-term goal is to determine whether acute changes in brain functional connectivity immediately after one treatment session can predict ultimate gains in motor function after completing multiple treatment sessions. The objective of this study is to determine feasibility and to examine association between change in brain functional connectivity after one session and motor gains after completion of all treatment sessions. This study is a prospective single-cohort longitudinal study. The treatment is task-practice therapy (3d/wk, 18-session) accompanied with concurrent imperceptible wrist vibration that is intended to prime the cortical sensorimotor network and enhance hand functional recovery in chronic stroke survivors. Hand function will be assessed before/after therapy and at 1-month follow-up. Connectivity will be assessed using fMRI and EEG before and after a treatment session.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-05
• Study Start: 2018-03-07
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Primary Completion: 2018-09-24
• Study Completion: 2018-09-24
• Results First Submitted: 2019-01-08
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-01
• Last Update Submitted: 2019-03-01
• Results First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Age = 18 or older
• At least 6 months post-stroke
• Moderate upper limb impairment with the ability to participate in hand task practices
• Fingertip touch sensory deficits (e.g., Monofilament>2.83, 2-point discrimination>5mm, sense of numbness, tingling)

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Exclusion Criteria

• Complete upper limb deafferentation
• Rigidity (Modified Ashworth Scale=5)
• Botulinum toxin injection within 3 months prior to enrollment or during enrollment
• Brainstem stroke
• Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
• Concurrent upper extremity rehabilitation therapy
• Language barrier or cognitive impairment that precludes following instructions or providing consent
• MRI incompatible.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy + vibration	task-practice therapy	Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.
therapy + vibration	Vibration	Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Primary Outcome Measures

Name	Time	Method
Mean Change in Hand Motor Function	Baseline to approximately 4 weeks after the completion of 18 therapy sessions.	Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Hand Motor Function	Baseline to approximately 4 weeks after the completion of 18 therapy sessions.	Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States