Smart Phone for Stroke Upper Limb Motor Function Training

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05217329
Collaborator
(none)
40
1
2
26.8
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: smart phone App rehabilitation
  • Other: conventional rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Smart Phone as an Assistive Technology for Stroke Upper Limb Motor Function Training - Feasibility and Treatment Effects Analysis
Actual Study Start Date :
Dec 31, 2018
Actual Primary Completion Date :
Jun 18, 2020
Actual Study Completion Date :
Mar 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: smart phone intervention group

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

Other: 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

Active Comparator: conventional group

stroke subjects receive conventional rehabilitation home program

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

Outcome Measures

Primary Outcome Measures

  1. FUGL-MEYER ASSESSMENT-UE, FMA) [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Occupational Therapy Kaohsiung Taiwan 807

Sponsors and Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Jyh-Jong Chang, PhD, Kaohsiung Medical University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05217329
Other Study ID Numbers:
  • KMUHIRB-E(I)-20190067
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 1, 2022
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022