The Therapeutic Effect of the Hand Robot on Stroke Patients Upper-lime Rehabilitation of Stroke Patients
- Conditions
- Stroke
- Interventions
- Device: RMTC finger-hand robot (Mirror Hand)Other: Conventional OT
- Registration Number
- NCT03841695
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
In the present study, the RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The participants will be randomized assigned to treatment group (TG, robot assisted treatment) and control group (CG, conventional treatment). In the experimental group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box \& block test、Brunnstrom recovery Stage, and motor activity log (MAL).
- Detailed Description
Clinical reports indicated the functional recovery of the distal part of upper limb in stroke patient needs time period longer than other body parts, and there is a limitation in the efficiency of conventional treatment on the distal part of upper limb. Robot assisted rehabilitation is a novel application in treatment. Rehabilitation robot is able to assist patients move the affected side through external power to achieve a repeated exercising and further evoke the motor function. In the present study, the wearable RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The patient (post stroke\>1 month) age from 20-90 years old with Modified Ashworth Scale ≦2, Brunnstrom Recovery Stage of Arm ≧ 2, Mini-Mental State Examination ≧24 will be included as our participation. The participants will be randomized assigned to treatment group (TG, robot assisted treatment, n=30) and control group (CG, conventional treatment, n=30). In the treatment group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system, the patient will also receive additional conventional treatment. In the control group, the patient will receive 100 minutes conventional treatment. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box \& block test、Brunnstrom recovery Stage, and motor activity log (MAL). The investigators will follow up the patient at the 3rd and 6th month after complete trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Modified Ashworth Scale, MAS≦2
- Brunnstrom Recovery Stage of Arm≧2
- Mini-Mental State Examination; MMSE≧24
- aged from 20-90 years
- first stroke ≧1 month
- poor cognitive ability (such as moderate to severe dementia, etc.) or mental illness (such as convulsions)
- wrist musculoskeletal system disease (such as fractures, tendon rupture, etc.) can not withstand external forces
- skin disorders (such as pressure sores, trauma, cellulitis, etc.)
- cerebellar stroke
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group RMTC finger-hand robot (Mirror Hand) Experimental group received Robot Assisted Training (RMTC finger-hand robot (Mirror Hand)) and traditional occupation therapy (Conventional OT) for 1 hour and forty minutes. Treatment Group Conventional OT Experimental group received Robot Assisted Training (RMTC finger-hand robot (Mirror Hand)) and traditional occupation therapy (Conventional OT) for 1 hour and forty minutes. Control Group Conventional OT Control group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes.
- Primary Outcome Measures
Name Time Method Change of Fugl-Meyer Assessment (FMA-Upper limb) Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up) Fugl-Meyer assessment is an stroke specific index for estimating the performance of motor function, Total scores of FMA-Upper limb ranged from 0-66.
- Secondary Outcome Measures
Name Time Method Change of Action Research Arm Test (ARAT) Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up) The ARAT is a measurement for evaluating the alteration of upper limb's motor function. Total scores of ARAT ranged from 0-57.
Change of Box & Block Test (BBT) Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up) The BBT is a measurement for test the unilateral gross manual dexterity. The number of blocks transferred from one compartment of a box to another in 1-minute is counted.
Change of Brunnstrom Recovery Stage (BRS) Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up) The BRS is a measurement tool for estimating the motor recovery consist of 6 sequential stages.
Change of Modified Ashworth Scale (MAS) Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up) The MAS is an index for estimating the muscle spasticity, minimal is MAS=0 and maximal is MAS=4.
Change of Motor Activity Log (MAL) Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up) The MAL is obtained by an interview for stroke patients to assess the use of their affected limb in the daily life, scaled from 0-5.
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital at Taoyuan
🇨🇳Taoyuan City, Taoyuan, Taiwan