Smart Phone for Stroke Upper Limb Motor Function Training

NCT ID: NCT05217329

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2021-03-26

Brief Summary

Stroke rehabilitation for stroke patients can enhance the upper and lower limb function, daily of daily activity improvement, and be beneficial to the family members' quality of life. Literature studies have supported the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to practice the mobile health model. Nevertheless, effects of tele-rehabilitation analysis for the proximal recovery of the stroke upper limbs still need to be explored. The main purpose of this research is to develop a smart phone with app system for stroke upper limb motor training, and further analyze its feasibility and treatment effects. The investigators randomly assigned chronic home stroke cases to the experimental group (n=20) and control group (n=20), each group received 8 weeks of treatment.

Detailed Description

Stroke rehabilitation (including occupational therapy and physical therapy) for stroke patients can enhance the upper and lower limb function, daily of daily activity improvement, and be beneficial to the family members' quality of life. Literature studies have supported the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to practice the mobile health model. This technology with remote rehabilitation have the important characteristics, including ease of use, high-intensity, repetitive exercises, and providing feedback information, to facilitate the recovery of training functions. Nevertheless, effects of tele-rehabilitation analysis for the proximal recovery of the stroke upper limbs still need to be explored. The main purpose of this research is to develop a smart phone with app system for stroke upper limb motor training, and further analyze its feasibility and treatment effects. The investigators randomly assigned chronic home stroke cases to the experimental group (n=20) and control group (n=20), each group received 8 weeks of treatment.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

smart phone intervention group

smart phone intervention group stroke subjects completed smart phone App tasks with affected arm or bilateral arm movement

Group Type: EXPERIMENTAL

smart phone App rehabilitation

Intervention Type: OTHER

stroke subjects use smart phone to complete therapeutic tasks 5 min/session total 8 sessions/day with affected arm or bilateral arm movement for 6 weeks

conventional group

stroke subjects receive conventional rehabilitation home program

Group Type: ACTIVE_COMPARATOR

conventional rehabilitation

Intervention Type: OTHER

stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)

Interventions

smart phone App rehabilitation

stroke subjects use smart phone to complete therapeutic tasks 5 min/session total 8 sessions/day with affected arm or bilateral arm movement for 6 weeks

Intervention Type: OTHER

conventional rehabilitation

stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Those who have used a smartphone for more than 3 months before the onset of the disease or at present
• Those who have no obvious vision loss and can read the text on mobile phones clearly
• Those who own a smart phone

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
• Feel severe Absence, FMA sensory score <12 points
• Other progressive diseases such as cancer, amyotrophic lateral sclerosis, multiple sclerosis, etc

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyh-Jong Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Department of Occupational Therapy

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Wu N, Gong E, Wang B, Gu W, Ding N, Zhang Z, Chen M, Yan LL, Oldenburg B, Xu LQ. A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study. JMIR Mhealth Uhealth. 2019 Jul 19;7(7):e13503. doi: 10.2196/13503.

Reference Type: RESULT

PMID: 31325288 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/31325288/

A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study

Other Identifiers

KMUHIRB-E(I)-20190067

Identifier Type: -

Identifier Source: org_study_id