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Completed

NCT Number: NCT05216094

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Occupational Therapy

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smart phone App

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 rehabilitation

Other

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

Primary outcomes

  1. Box and Block Test

    Time frame: pre-test, post-test(Change from pre-test Box and Block Test after 12 weeks' intervention), and follow-up(Change from post-test Box and Block Test at one month )

    The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.

  2. FUGL-MEYER ASSESSMENT-UE, FMA)

    Time frame: pre-test, post-test(Change from pre-test FUGL-MEYER ASSESSMENT-UE after 12 weeks' intervention), and follow-up(Change from post-test FUGL-MEYER ASSESSMENT-UE at one month )

    Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke.

  3. Grip Strength Assessment

    Time frame: pre-test, post-test(Change from pre-test Grip Strength Assessment after 12 weeks' intervention), and follow-up(Change from post-test Grip Strength Assessment at one month )

    Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.

  4. System Usability Scale(SUS)

    Time frame: only post-test(after 12 weeks' intervention)

    The System Usability Scale, is a simple survey that provides a high-level score for the usability of a product. The score is a value between 0 and 100, with higher values indicating better usability.

  5. Motor Activity Log (MAL-28)

    Time frame: pre-test, post-test(Change from pre-test Motor Activity Log after 12 weeks' intervention), and follow-up(Change from post-test Motor Activity Log at one month )

    The Motor Activity Log (MAL) is a subjective measure of an individual's real life functional upper limb performance.

  6. Stroke Impact Scale(SIS)

    Time frame: pre-test, post-test(Change from pre-test Stroke Impact Scale after 12 weeks' intervention), and follow-up(Change from post-test Stroke Impact Scale at one month )

    The purpose of this questionnaire is to evaluate how stroke has impacted your health and life. The score is a value between 0 and 100, with higher values indicating better recover.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Effects of Applying Task-oriented Practice Combined With Behavior Changes Strategy and Mhealth App on the Improvement of Upper Limb Function for Patients With Chronic Stroke

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2022
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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