Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients

NCT ID: NCT03917511

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-17

Study Completion Date

2021-04-20

Brief Summary

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The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.

Detailed Description

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Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training.

This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic training with mirror therapy

20 minutes mirror therapy followed by 40 minutes robotic-assisted training

Group Type EXPERIMENTAL

Robotic training with mirror therapy

Intervention Type BEHAVIORAL

Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).

Robotic-assisted training

20 minutes sham mirror therapy followed by 40 minutes robotic-assisted training

Group Type SHAM_COMPARATOR

Robotic-assisted training

Intervention Type BEHAVIORAL

The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.

Interventions

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Robotic training with mirror therapy

Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).

Intervention Type BEHAVIORAL

Robotic-assisted training

The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Brain injury more than 3 months.
2. Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
3. The myoelectric signal can be detected to activate the instrument
4. unilateral paresis (FMA score\<60)
5. no serious cognitive impairment (i.e., Mini Mental State Exam score \> 24)
6. can provide informed consent

Exclusion Criteria

1. Other neurological disease
2. Complete sense of body defect
3. Inability to understand instructions
4. current participation in any other research
5. Botulinum Toxin injection within 3 months
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

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Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

References

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Chen YW, Li KY, Lin CH, Hung PH, Lai HT, Wu CY. The effect of sequential combination of mirror therapy and robot-assisted therapy on motor function, daily function, and self-efficacy after stroke. Sci Rep. 2023 Oct 6;13(1):16841. doi: 10.1038/s41598-023-43981-3.

Reference Type DERIVED
PMID: 37803096 (View on PubMed)

Other Identifiers

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201801025B0

Identifier Type: -

Identifier Source: org_study_id

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