Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

NCT ID: NCT01523925

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-03-31

Brief Summary

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

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combined dCIT with FET

Combined distributed constraint induced therapy with functional electrical therapy

Group Type: EXPERIMENTAL

dCIT

Intervention Type: BEHAVIORAL

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.

Functional electrical stimulation

Intervention Type: BEHAVIORAL

Combined BAT with FET

Combined bilateral arm treatment with functional electrical therapy

Group Type: EXPERIMENTAL

BAT

Intervention Type: BEHAVIORAL

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.

Functional electrical stimulation

Intervention Type: BEHAVIORAL

Control intervention group

Control intervention

Group Type: ACTIVE_COMPARATOR

Control intervention group

Intervention Type: BEHAVIORAL

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.

dCIT

distributed constraint induced therapy

Group Type: EXPERIMENTAL

dCIT

Intervention Type: BEHAVIORAL

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.

BAT

bilateral arm treatment

Group Type: EXPERIMENTAL

BAT

Intervention Type: BEHAVIORAL

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.

Interventions

dCIT

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.

Intervention Type: BEHAVIORAL

BAT

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.

Intervention Type: BEHAVIORAL

Control intervention group

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.

Intervention Type: BEHAVIORAL

Functional electrical stimulation

Intervention Type: BEHAVIORAL

Other Intervention Names

distributed constraint induced therapy; bilateral arm training; Control intervention; FES

Eligibility Criteria

Inclusion Criteria

• The onset duration more than 6 months
• An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
• No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
• The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
• No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
• Considerable nonuse of the affected upper extremity (an AOU score < 2.5 of Motor Activity Log)

Exclusion Criteria

• Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
• Excessive pain in any joint that might limit participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

98-3827B

Identifier Type: OTHER

Identifier Source: secondary_id

NSC 99-2314-B-182-014-MY3

Identifier Type: -

Identifier Source: org_study_id