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Effects of Mhealth App on the Improvement of Upper Limb Function for Patients With Chronic Stroke

NCT ID: NCT05216094

Last Updated: 2023-12-29

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2023-07-31

Brief Summary

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The main purpose is to develop a mobile health app that combines behavioral change technology and task-oriented exercise strategies to provide a technology-assisted training system for upper limb motor function in home stroke cases, and to analyze its feasibility and therapeutic benefits. It is estimated that 50 chronic stroke cases will be recruited and randomly assigned to the experimental group (n=25) and the control group (n=25). The experimental group received a 12-week action health App combined with behavioral change technology and task-oriented upper limb exercise strategy intervention. The control group received a 12-week sham control and a traditional home rehabilitation intervention program. Both groups received pre-test, post-test (12 weeks) and follow-up assessment (4 weeks). This study will adopt a double-blind evaluation design.

Detailed Description

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The main purpose is to develop a mobile health app that combines behavioral change technology and task-oriented exercise strategies to provide a technology-assisted training system for upper limb motor function in home stroke cases, and to analyze its feasibility and therapeutic benefits. It is estimated that 50 chronic stroke cases will be recruited and randomly assigned to the experimental group (n=25) and the control group (n=25). The experimental group received a 12-week action health App combined with behavioral change technology and task-oriented upper limb exercise strategy intervention. The control group received a 12-week sham control and a traditional home rehabilitation intervention program. Both groups received pre-test, post-test (12 weeks) and follow-up assessment (4 weeks). This study will adopt a double-blind evaluation design, and the evaluation contents include Fugl-Meyer Upper Limb Motor Function Scale, Grip Strength Assessment, Box and Block Test, MAL-28, Stroke Impact Scale and System Utility Scale. Data analysis included descriptive statistics, Repeated ANOVA, and correlation analysis.

The results of this research are expected to develop a mobile health app that combines behavioral change technology and task-oriented exercise strategies, which can be applied to stroke patients at home or in the community to promote the execution of high-intensity and high-repetition upper limb motor function exercises, thereby improving upper limb and daily life. life function.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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smart phone intervention group

smart phone intervention group stroke subjects completed smart phone App tasks with affected upper limb or bilateral arm movement for 12 weeks

Group Type EXPERIMENTAL

smart phone App

Intervention Type OTHER

stroke subjects completed tasks-oriented program demoed in the smart phone app with affected upper limb or bilateral arm movement for 12 weeks

conventional group

stroke subjects receive conventional rehabilitation home program for 12 weeks

Group Type ACTIVE_COMPARATOR

conventional rehabilitation

Intervention Type OTHER

stroke subjects receive conventional rehabilitation home program with smart phone app ,without task-oriented program demoed function, for 12 weeks

Interventions

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smart phone App

stroke subjects completed tasks-oriented program demoed in the smart phone app with affected upper limb or bilateral arm movement for 12 weeks

Intervention Type OTHER

conventional rehabilitation

stroke subjects receive conventional rehabilitation home program with smart phone app ,without task-oriented program demoed function, for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>20, and first onset
* Unilateral Hemiplegia
* No obvious cognitive impairment (Mini-Mental State Examination (MMSE) score \> 23)
* The FMA upper limb movement score is above 30 points, and there are partial extension movements of the affected fingers and wrists
* Ability to operate a smartphone independently before or at present
* Those who have no obvious vision loss and can read mobile phone text clearly

Exclusion Criteria

* Language barriers or aphasia
* Other orthopedic diseases (such as severe shoulder pain, joint contractures) or nerve damage (such as peripheral nerve damage) that affect the movement of the upper limbs
* People with abnormal cardiopulmonary function who are not suitable for active sports
* Feel severe Absence, FMA sensory score \<12 points
* Other progressive diseases such as cancer, amyotrophic lateral sclerosis, multiple sclerosis, etc
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jyh-Jong Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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Department of Occupational Therapy

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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Szturm T, Imran Z, Pooyania S, Kanitkar A, Mahana B. Evaluation of a Game Based Tele Rehabilitation Platform for In-Home Therapy of Hand-Arm Function Post Stroke: Feasibility Study. PM R. 2021 Jan;13(1):45-54. doi: 10.1002/pmrj.12354. Epub 2020 Apr 13.

Reference Type RESULT
PMID: 32107868 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/32107868/

Evaluation of a Game Based Tele Rehabilitation Platform for In-Home Therapy of Hand-Arm Function Post Stroke: Feasibility Study

Other Identifiers

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KMUHIRB-E(I)-20200437

Identifier Type: -

Identifier Source: org_study_id