The Therapeutic Effect of the Hand Robot on Stroke Patients Upper-lime Rehabilitation of Stroke Patients

The Therapeutic Effect of the Rehabotics Medical Technology Corporation (RMTC) Finger-hand Robot on Upper-limb Rehabilitation of Stroke Patients

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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: RMTC finger-hand robot (Mirror Hand); Other: Conventional OT

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Taoyuan City, Taoyuan, Taiwan, 333
      • Chang Gung Memorial Hospital at Taoyuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Experimental group received Robot Assisted Training (RMTC finger-hand robot (Mirror Hand)) and traditional occupation therapy (Conventional OT) for 1 hour and forty minutes.	Device: RMTC finger-hand robot (Mirror Hand); The robotic hand will apply on the patient's affected hand and the sensor glove will apply on the patient's un-affected hand, the patient can manipulate their affected hand by their un-affected hand and do the task oriented bimanual training.; Other: Conventional OT; The focus of occupational therapy is to help individuals achieve health, well-being, and participation in life through engagement in activities (American Occupational Therapy Association [AOTA], 2014). For stroke rehabilitation, occupational therapy includes retraining in self-care skills, addressing ongoing deficits such as weakness, sensory loss, and cognitive impairments that limit engagement in activities of daily living, and training in community reintegration and modifying tasks or environments.
Active Comparator: Control Group; Control group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes.	Other: Conventional OT; The focus of occupational therapy is to help individuals achieve health, well-being, and participation in life through engagement in activities (American Occupational Therapy Association [AOTA], 2014). For stroke rehabilitation, occupational therapy includes retraining in self-care skills, addressing ongoing deficits such as weakness, sensory loss, and cognitive impairments that limit engagement in activities of daily living, and training in community reintegration and modifying tasks or environments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Fugl-Meyer Assessment (FMA-Upper limb)	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Modified Ashworth Scale (MAS)	The MAS is an index for estimating the muscle spasticity, minimal is MAS=0 and maximal is MAS=4.	Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Action Research Arm Test (ARAT)	The ARAT is a measurement for evaluating the alteration of upper limb's motor function. Total scores of ARAT ranged from 0-57.	Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Brunnstrom Recovery Stage (BRS)	The BRS is a measurement tool for estimating the motor recovery consist of 6 sequential stages.	Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Box & Block Test (BBT)	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.	Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Motor Activity Log (MAL)	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.	Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 201800703A3C601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No