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

K

Kaohsiung Medical University

Status

Completed

Conditions

Stroke

Treatments

Other: smart phone App
Other: conventional rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05216094
KMUHIRB-E(I)-20200437

Details and patient eligibility

About

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.

Full description

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.

Enrollment

48 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

smart phone intervention group
Experimental group
Description:
smart phone intervention group stroke subjects completed smart phone App tasks with affected upper limb or bilateral arm movement for 12 weeks
Treatment:
Other: smart phone App
conventional group
Active Comparator group
Description:
stroke subjects receive conventional rehabilitation home program for 12 weeks
Treatment:
Other: conventional rehabilitation

Trial contacts and locations

1

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Central trial contact

Jyh-Jong Chang, PhD

Data sourced from clinicaltrials.gov

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