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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Stroke

Treatments

Other: Conventional OT
Device: RMTC finger-hand robot (Mirror Hand)

Study type

Interventional

Funder types

Other

Identifiers

NCT03841695
201800703A3C601

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Treatment Group
Experimental group
Description:
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:
Device: RMTC finger-hand robot (Mirror Hand)
Other: Conventional OT
Control Group
Active Comparator group
Description:
Control group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes.
Treatment:
Other: Conventional OT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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