Clinical trial NCT03841695: The Therapeutic Effect of the Hand Robot on Stroke Patients Upper-lime Rehabilitation of Stroke Patients
Official title: The Therapeutic Effect of the Rehabotics Medical Technology Corporation (RMTC) Finger-hand Robot on Upper-limb Rehabilitation of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Fugl-Meyer Assessment (FMA-Upper limb)
timeFrame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Secondary outcomes:
measure: Change of Modified Ashworth Scale (MAS)
timeFrame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
measure: Change of Action Research Arm Test (ARAT)
timeFrame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
measure: Change of Brunnstrom Recovery Stage (BRS)
timeFrame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
measure: Change of Box & Block Test (BBT)
timeFrame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
measure: Change of Motor Activity Log (MAL)
timeFrame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital at Taoyuan
state: Taoyuan
Study officials:
References:
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
citation: Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
citation: Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
citation: CARROLL D. A QUANTITATIVE TEST OF UPPER EXTREMITY FUNCTION. J Chronic Dis. 1965 May;18:479-91. doi: 10.1016/0021-9681(65)90030-5. No abstract available.
citation: Crow JL, Lincoln NB, Nouri FM, De Weerdt W. The effectiveness of EMG biofeedback in the treatment of arm function after stroke. Int Disabil Stud. 1989 Oct-Dec;11(4):155-60. doi: 10.3109/03790798909166667.
citation: Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.