Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

Withdrawn

Phase N/A Results N/A

Trial Description

This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.

Detailed Description

Two theory-based, task-oriented approaches are distributed CIT (dCIT) and robot-assisted Bilateral training(BAT). CIT/dCIT involves massed practice of the affected arm and restraint of the unaffected arm. BAT involves repetitive practice of symmetrical bilateral movements on robot. Both are evident to improve motor performance, motor control or daily function in high functioning patients. These dCIT and BAT have their own limitations for motor-deficit rehabilitation after stroke, i.e. only appropriate for high-functioning or mildly motor impaired patients. Functional electrical therapy, an innovative technology, is proposed as an adjunct to these behavioral approaches to assist in movement execution. Functional electrical therapy is used to increase the electric activity of muscles for movement and the active range of motion in low functioning patients. Combining functional electrical therapy into CIT or BAT may extend the utility of these two behavioral approaches beyond patients with mild motor deficits and could expedite the progress of motor recovery. This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with dCIT or with BAT.

Conditions

Interventions

  • Functional Electrical Stimulation Device
    ARM 1: Kind: Experimental
    Label: Combined dCIT with FET
    Description: Combined distributed constraint induced therapy with functional electrical therapy
    ARM 2: Kind: Experimental
    Label: Combined BAT with FET
    Description: Combined bilateral arm treatment with functional electrical therapy
  • Combined dCIT with FET Behavioral
    Other Names: Combined dCIT with FET
    Intervention Desc: This combined dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities and the functional electrical stimulation will assist patients to complete the task in terms of helping part of task where the patient is unable to perform.
    ARM 1: Kind: Experimental
    Label: Combined dCIT with FET
    Description: Combined distributed constraint induced therapy with functional electrical therapy
  • Combined BAT with FET Behavioral
    Other Names: Combined BAT with FET
    Intervention Desc: The combined BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity in functional tasks in symmetric or alternating patterns for 1.5 hours/day, 5 days/week for 4 weeks. These functional tasks also emphasize upper extremity movements involved in daily activities, but focuses on both upper extremities moving synchronously. During performing the therapeutic activities, the functional electrical stimulation will activate the target muscles to assist in completing the task.
    ARM 1: Kind: Experimental
    Label: Combined BAT with FET
    Description: Combined bilateral arm treatment with functional electrical therapy
  • Control intervention group Behavioral
    Other Names: CI
    Intervention Desc: The conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks). Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities.
    ARM 1: Kind: Experimental
    Label: Control intervention group
    Description: Control intervention
  • DCIT Behavioral
    Other Names: distributed constraint induced therapy
    Intervention Desc: This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities.
    ARM 1: Kind: Experimental
    Label: Combined dCIT with FET
    Description: Combined distributed constraint induced therapy with functional electrical therapy
    ARM 2: Kind: Experimental
    Label: dCIT
    Description: distributed constraint induced therapy
  • BAT Behavioral
    Other Names: bilateral arm training
    Intervention Desc: The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
    ARM 1: Kind: Experimental
    Label: Combined BAT with FET
    Description: Combined bilateral arm treatment with functional electrical therapy
    ARM 2: Kind: Experimental
    Label: BAT
    Description: bilateral arm treatment

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Kinamatic analysis of arm movements 2011-2013 No
Secondary Clinical assessment 2011-2013 No
Primary Movement time (MT) Baseline and change from baseline in MT at 4 weeks No
Primary Total displacement (TD) Baseline and change from baseline in TD at 4 weeks No
Primary Percentage of peak velocity (PPV) Baseline and change from baseline in PPV at 4 weeks No
Secondary Fugl-Meyer Assessment (FMA) Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks No
Secondary Medical Research Council scale (MRC) Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks No
Secondary Modified Ashworth Scale (MAS) Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks No
Secondary MYOTON-3 Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks No
Secondary Motor Activity Log (MAL) Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks No
Secondary ABILHAND Questionnaire Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks No
Secondary Reintegration of Normal Living Index (RNL) Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks No

Sponsors