Clinical trial NCT02319785: Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
Official title: Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
name: Chang Gung University
name: Chang Gung Memorial Hospital
name: Cheng-Hsin General Hospital
name: Lo-Sheng Sanatorium
First posted: 2014-12-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of kinematic analyses
timeFrame: within three days before and immediately after the intervention
measure: change of Fugl-Meyer Assessment
timeFrame: within three days before and immediately after the intervention
Secondary outcomes:
measure: change of 10-Meter Walk Test (10MWT)
timeFrame: within three days before and immediately after the intervention
measure: change of Wolf Motor Function Test
timeFrame: within three days before and immediately after the intervention
measure: change of Functional Independence Measure
timeFrame: within three days before and immediately after the intervention
measure: change of The Action Research Arm Test
timeFrame: within three days before and immediately after the intervention
Other outcomes:
measure: change of Medical Research Council scale
timeFrame: within three days before and immediately after the intervention
measure: change of Functional Ambulation Categories
timeFrame: within three days before and immediately after the intervention
measure: change of Modified Ashworth Scale
timeFrame: within three days before and immediately after the intervention
measure: change of Motor Activity Log
timeFrame: within three days before and immediately after the intervention
measure: change of ABILHAND Questionnaire
timeFrame: within three days before and immediately after the intervention
measure: change of Stroke Impact Scale Version 3.0
timeFrame: within three days before and immediately after the intervention
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: National Taiwan University
name: Keh-Chung Lin, Dr.
role: STUDY_DIRECTOR
affiliation: Cathay General Hospital
name: Chia-Yi Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cathay General Hospital
name: Ming-wei Lee
role: PRINCIPAL_INVESTIGATOR
References: