Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

Cerebrovascular Accident Clinical Trial

Official title:

Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01523925
• Other study ID #: NSC 99-2314-B-182-014-MY3
• Secondary ID: 98-3827B
• Status: Withdrawn
• Phase: N/A
• First received: January 30, 2012
• Last updated: February 10, 2015
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• 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.
• 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.
• 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.
• Functional electrical stimulation

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan County

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement time (MT)	The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. MT is the interval between movement onset and offset.	Baseline and change from baseline in MT at 4 weeks	No
Primary	Total displacement (TD)	The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand in three-dimensional space and is a measure of trajectory smoothness.	Baseline and change from baseline in TD at 4 weeks	No
Primary	Percentage of peak velocity (PPV)	The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. The PPV reflects the duration of the acceleration phase relative to the deceleration phase and indicates the type of movement strategy selected for a motor action.	Baseline and change from baseline in PPV at 4 weeks	No
Secondary	Fugl-Meyer Assessment (FMA)	The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.	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)	The MRC scale examines the muscle strength of the affected arm and is reliable measurement with score ranged from 0 (no contraction) to 5 (normal power).	Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks	No
Secondary	Modified Ashworth Scale (MAS)	The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE. A higher score indicating more spasticity.	Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks	No
Secondary	MYOTON-3	Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.	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)	The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.	Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks	No
Secondary	ABILHAND Questionnaire	ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.	Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks	No
Secondary	Reintegration of Normal Living Index (RNL)	The RNL is used to measure the satisfaction with community reintegration. It scores on a 4-point ordinal scale, with higher scores indicating a higher level of satisfaction.	Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks	No