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Completed

NCT Number: NCT05217329

Smart Phone for Stroke Upper Limb Motor Function Training

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.

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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

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Occupational Therapy

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

smart phone App rehabilitation

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 rehabilitation

Other

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

Primary outcomes

  1. FUGL-MEYER ASSESSMENT-UE, FMA)

    Time frame: pre-test, post-test(Change from pre-test FUGL-MEYER ASSESSMENT-UE after 8 weeks' intervention)

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

  2. Box and Block Test

    Time frame: pre-test, post-test(Change from pre-test Box and Block Test after 8 weeks' intervention)

    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.

  3. Grip Strength Assessment

    Time frame: pre-test, post-test(Change from pre-test Grip Strength Assessment after 8 weeks' intervention)

    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

    Time frame: only post-test(after 8 weeks' intervention)

    The System Usability Scale, or SUS, is a simple survey that provides a high-level score for the usability of a product.

  5. The Ruff 2 & 7 Selective Attention Test

    Time frame: pre-test, post-test(Change from pre-test The Ruff 2 & 7 Selective Attention Test after 8 weeks' intervention)

    The Ruff 2 and 7 Selective Attention Test (RSAT) is designed to measure selective attention.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Smart Phone as an Assistive Technology for Stroke Upper Limb Motor Function Training - Feasibility and Treatment Effects Analysis

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 1, 2022
Registry last updated
Feb 1, 2022

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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