A Smartphone Application for a Self-directed Upper Limb Therapy After Stroke

NCT06190795 | Completed

• 1 other identifier: 2023/00507
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to investigate a newly developed AI smartphone application's feasibility, usefulness in improving users' experience, effect on adherence, UL use and recovery after stroke. The study is a prospective randomized controlled trial (RCT) to compare the implementation of AMPLIFY, a self-directed UL programme for people with stroke in two modes of delivery- hardcopy manual versus the mobile application. Eighty people with stroke within 4 weeks of stroke will be randomly allocated to either the experimental group (smartphone app) or control group (hardcopy manual) to undergone four weeks of AMPLIFY program. To compare the clinical effects of delivery AMPLIFY program via smartphone app versus hardcopy manual, assessments will be done at three time points- pre-intervention, post-intervention and three months post-intervention.

Conditions

Stroke

Keywords

Upper Limb; Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Action Research Arm Test

  Change in Action Research Arm Test (minimum score 0 - maximum score 57; the higher the score the better the upper limb performance)

  Change from pre-intervention to immediate post-intervention

Secondary Outcomes (18)

• Change in Action Research Arm Test

  Change from immediate post-intervention to 3 month post-intervention

• Change in Upper Limb Self-Efficacy Test

  Change from pre-intervention to immediate post-intervention

• Change in Upper Limb Self-Efficacy Test

  Change from immediate post-intervention to 3 month post-intervention

• Change in Rating of Everyday Arm-use in the Community and Home

  Change from pre-intervention to immediate post-intervention

• Change in Rating of Everyday Arm-use in the Community and Home

  Change from immediate post-intervention to 3 month post-intervention

Study Arms (2)

Smartphone Application

EXPERIMENTAL

AMPLIFY Programme delivered via smartphone application with 2 levels. Level 1 is catered for people with stroke with ARAT score \<34, while Level 2 is catered for people with stroke with ARAT score \>=34. Five to 6 exercises will be prescribed to the stroke participants for each session to be performed independently or with the help of caregiver. Stroke participants are to performed exercises 3 sessions per day for 6 days per week. Stroke participants are to use paretic UL to perform functional activities prescribed whenever needed throughout the day. AMPLIFY programme will last for 4 weeks. If the stroke participants are discharged before 4 weeks, the participants will continue at home with the reviews being performed by the therapists via tele-rehabilitation. Frequency of reviews for the experimental group will be: Week1 (2x); Week2 (1x); Week3 (x0); Week4 (x1).

Other: AMPLIFY Smartphone Application

Hardcopy Manual

ACTIVE COMPARATOR

AMPLIFY Programme will be delivered via hardcopy manual. AMPLIFY Programme consists of two booklets (Booklet 1 and Booklet 2). Booklet 1 is catered for people with stroke with ARAT score \<34, while Booklet 2 is catered for people with stroke with ARAT score \>=34. Five to 6 exercises will be prescribed to the stroke participants for each session to be performed independently or with the help of caregiver. Stroke participants are to performed the exercises 3 sessions per day for 6 days per week. Stroke participants are to use paretic UL to perform functional activities prescribed whenever needed throughout the day. AMPLIFY programme will last for 4 weeks. If stroke participants are discharged before AMPLIFY programme ends, the participants will continue at home with the reviews being performed by the therapists via tele-rehabilitation. Frequency of reviews for the control group will be as follows: Week1 (3x); Week2 (2x); Week3 (x1); Week4 (x1).

Other: Hardcopy Manual

Interventions

AMPLIFY Smartphone Application OTHER

AMPLIFY Smartphone Application enables prescription and progression of exercises/functional activities, while offering immediate feedback on upper limb movement performed, real-time logging and monitoring of adherence through virtual platform

Smartphone Application

Hardcopy Manual OTHER

Hardcopy Manual

Hardcopy Manual

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke (confirmed by CT/MRI scans)
• ≤four weeks post-stroke
• Montreal Cognitive Assessment (MOCA)\>=21
• Finger extension Medical Research Council (MRC) \>=1
• Fugl Meyer Upper Limb score \<60 or NIHSS Motor Arm section score\>=2
• Potential discharge to home (able to do tele-rehabilitation for review)

You may not qualify if:

• Bilateral stroke
• Montreal Cognitive Assessment (MOCA)\<21
• Paretic upper limb numeric pain rating scale (NPRS)\>5
• Reduced paretic upper limb use prior to stroke episode (e.g. frozen shoulder, fracture, etc)
• Reduced paretic upper limb use due to orthopaedic problems such as fracture in existing stroke episode
• Medically unstable
• Neglect as ascertained by treatment team
• Severe behavioural disturbance or agitation or epilepsy or untreated depression or psychiatric conditions
• Pregnancy or lactation states

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Lay Fong Chin

Singapore, Singapore, 307382, Singapore

Location

Related Publications (1)

• Chin LF, Hayward KS, Chai ALM, Brauer SG. A Self-Empowered Upper Limb Repetitive Engagement Program to Improve Upper Limb Recovery Early Post-Stroke: Phase II Pilot Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):836-848. doi: 10.1177/15459683211032967. Epub 2021 Jul 19.

  PMID: 34281405 BACKGROUND

Related Links

• pubmed link to journal article

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to which group the research participants are in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Blinded Controlled Trial

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: March 11, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)