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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
RMTC finger-hand robot (Mirror Hand)
Conventional OT
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chang Gung Memorial Hospital at Taoyuan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change of Brunnstrom Recovery Stage (BRS)
The BRS is a measurement tool for estimating the motor recovery consist of 6 sequential stages.
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.
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.

Full Information

First Posted
December 20, 2018
Last Updated
May 24, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03841695
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes.
Intervention Type
Device
Intervention Name(s)
RMTC finger-hand robot (Mirror Hand)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional OT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Fugl-Meyer Assessment (FMA-Upper limb)
Description
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.
Time Frame
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 Measure Information:
Title
Change of Modified Ashworth Scale (MAS)
Description
The MAS is an index for estimating the muscle spasticity, minimal is MAS=0 and maximal is MAS=4.
Time Frame
Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Title
Change of Action Research Arm Test (ARAT)
Description
The ARAT is a measurement for evaluating the alteration of upper limb's motor function. Total scores of ARAT ranged from 0-57.
Time Frame
Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Title
Change of Brunnstrom Recovery Stage (BRS)
Description
The BRS is a measurement tool for estimating the motor recovery consist of 6 sequential stages.
Time Frame
Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Title
Change of Box & Block Test (BBT)
Description
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.
Time Frame
Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Title
Change of Motor Activity Log (MAL)
Description
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.
Time Frame
Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital at Taoyuan
City
Taoyuan City
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1135616
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.
Results Reference
background
PubMed Identifier
6932734
Citation
Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
Results Reference
background
PubMed Identifier
3160243
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.
Results Reference
background
PubMed Identifier
14293031
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.
Results Reference
background
PubMed Identifier
2701823
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.
Results Reference
background
PubMed Identifier
7333761
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.
Results Reference
background

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

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