Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients

Cathay General Hospital

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Behavioral: Mirror therapy; Behavioral: Bilateral RAT; Behavioral: Unilateral RAT; Behavioral: Conventional rehabilitation; Behavioral: RAT-NMES; Behavioral: RAT-MT

Study type: Interventional

Funder types: Other

Identifiers

NCT02319785

CathayGH

Details and patient eligibility

About

The main purpose of this study is to examine the treatment effects and the combined-therapy of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in the investigators trial to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.

Full description

Stroke remains a leading cause of permanent disability in Taiwan and many other countries. The high incidence of stroke and the decreased mortality from stroke which imply the urgent needs for effective rehabilitation. Various contemporary rehabilitation interventions focused on restoring upper limb motor function have been advocated for stroke rehabilitation. Robot-assisted therapy (RAT), one current prominent activity-based approach, has emerged that incorporates therapeutic elements for success in stroke motor rehabilitation: combined with neuromuscular electrical stimulation and mirror therapy into its design. However, scientific evidence for the effects of the RAT and its combined-therapy on functional outcomes (e.g., motor and daily functions) in stroke patients remains limited. Furthermore, there is a need to identify the proper protocol and intervention type. This research project will use randomized controlled trial design to address these issues.

The main purpose of this study is to examine the treatment effects and the combined-therapy of the RAT by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in our trail to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.

The inclusion criteria of subjects are first-ever unilateral stroke with more than 3 months onset ; (2) an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment; (3) no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers); (4) be able to follow study instructions and perform study tasks; (5) without upper limb fracture within 3 months; (6) lack of participation in any experimental rehabilitation or drug studies during the study period; (7) welling to provide written informed consent ; and (8) able to realize and respond to oral instructions. Patients with neural or psychological medical history, recurrent stroke or attack by epilepsy during the intervention will be excluded. Expected sample size is 120.

Subjects will be randomly assigned to one of the six groups: (1) robot-assisted therapy combined with neuromuscular electrical stimulation (RAT-NMES) ; (2) robot-assisted therapy combined with mirror therapy (RAT-MT) ; (3) mirror therapy group; (4) unilateral robot-assisted therapy group ; (5) bilateral robot-assisted therapy and (6) conventional rehabilitation (CR). All subjects in the study will receive treatment from registered occupational therapist 1.5 hours each day, five days a week for four weeks. Pretest and posttest will be hold before and after the intervention to check if the subjects had any improvement. The outcome measures are kinematic analysis of the upper and lower limb movement variables, the Fugl-Meyer Assessment (FMA), Medical Research Council scale (MRC), MYOTON-3, accelerometers, Functional Ambulation Category (FAC), Ten-meter walk test, Functional Independence Measure (FIM), Stroke Impact Scale (SIS), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), ABILHAND, Motor Activity Log (MAL), and Modified Ashworth Scale (MAS). All the data will be calculated by SPSS 13.0. Subject's age, sex, time after stroke in each group will be compared by descriptive statistics. The change of outcome measures after intervention in each group will be calculated by ANOVA to see if combined therapy had better effectiveness than the other groups.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. first-ever unilateral stroke with more than 3 months onset ;
2. an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment;
3. no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers);
4. be able to follow study instructions and perform study tasks;and
5. willing to provide written informed consent.

Exclusion criteria

1. with neural or psychological medical problem that may influence the study;
2. with severe joint pain;
3. with upper limb fracture within 3 months;
4. participation in any experimental rehabilitation or drug studies during the study period; and
5. refusing to provide written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 6 patient groups

RAT-NMES

Experimental group

Description:

The combined treatment of robot-assisted therapy and neuromuscular electrical stimulation.

Treatment:

Behavioral: RAT-NMES

RAT-MT

Experimental group

Description:

The combined treatment of robot-assisted therapy and mirror therapy.

Treatment:

Behavioral: RAT-MT

Mirror therapy

Active Comparator group

Description:

Patients practice motion in a mirror box, and look into mirror while practicing.

Treatment:

Behavioral: Mirror therapy

Unilateral RAT

Experimental group

Description:

Unilateral robot-assisted therapy provided by InMotion Isokinetic Testing and Evaluation System.

Treatment:

Behavioral: Unilateral RAT

Bilateral RAT

Active Comparator group

Description:

Bilateral robot-assisted therapy provided by Bi-Manu-Track.

Treatment:

Behavioral: Bilateral RAT

Conventional rehabilitation

Active Comparator group

Description:

Conventional rehabilitation provided by therapist.

Treatment:

Behavioral: Conventional rehabilitation