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

NCT03841695 | Completed

• 1 other identifier: 201800703A3C601
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Treatment Group

EXPERIMENTAL

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); Other: Conventional OT

Control Group

ACTIVE COMPARATOR

Control group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes.

Other: Conventional OT

Interventions

RMTC finger-hand robot (Mirror Hand) DEVICE

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.

Treatment Group

Conventional OT OTHER

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.

Control Group; Treatment Group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital at Taoyuan

Taoyuan, Taoyuan, 333, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 1135616 BACKGROUND

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

  PMID: 6932734 BACKGROUND

• 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.

  PMID: 3160243 BACKGROUND

• 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.

  PMID: 14293031 BACKGROUND

• 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.

  PMID: 2701823 BACKGROUND

• 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.

  PMID: 7333761 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: February 15, 2019
• Study Start: December 21, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)