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Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Withdrawn

Conditions

Cerebrovascular Accident

Treatments

Behavioral: BAT
Behavioral: Functional electrical stimulation
Behavioral: dCIT
Behavioral: Control intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT01523925
NSC 99-2314-B-182-014-MY3
98-3827B (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

0 participants in 5 patient groups

Combined dCIT with FET
Experimental group
Description:
Combined distributed constraint induced therapy with functional electrical therapy
Treatment:
Behavioral: dCIT
Behavioral: Functional electrical stimulation
Combined BAT with FET
Experimental group
Description:
Combined bilateral arm treatment with functional electrical therapy
Treatment:
Behavioral: Functional electrical stimulation
Behavioral: BAT
Control intervention group
Active Comparator group
Description:
Control intervention
Treatment:
Behavioral: Control intervention group
dCIT
Experimental group
Description:
distributed constraint induced therapy
Treatment:
Behavioral: dCIT
BAT
Experimental group
Description:
bilateral arm treatment
Treatment:
Behavioral: BAT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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