StrokeNCT06190795
A Smartphone Application for a Self-directed Upper Limb Therapy After Stroke
A study testing AMPLIFY Smartphone Application and Hardcopy Manual in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- AMPLIFY Smartphone Application and Hardcopy Manual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Mar 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Neglect as ascertained by treatment team
- Severe behavioural disturbance or agitation or epilepsy or untreated depression or psychiatric conditions
- Pregnancy or lactation states
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of AI-powered Interactive Smartphone Application for a Self-directed Upper Limb Therapy Implementation After Stroke
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.
Read the detailed description
Background To intensify practice to influence neuroplasticity to optimize UL recovery after stroke, it is important to empower people with stroke to perform self-directed UL therapy outside therapy. However, it has been found that increasing UL practice is often challenging with high level of inactivity found in people with stroke during rehabilitation. Traditionally, self-directed program has been delivered via hard copy manuals. Hardcopy manuals are often cumbersome and difficult to retrieve and handle, especially for those with moderate/severe UL impairment. Hence a more accessible format of exercise/activities instructions is needed. There is lack of reminders for people with stroke to keep up to prescribed exercise regime. This may affect adherence as some may not remember the prescribed practice sessions. Without immediate feedback of UL movement performed during self-practice, people with stroke may continue with compensatory movement performance without correction. This may in turns hinder UL recovery.
The aim of this study is to overcome these challenges by developing an AI-powered interactive smartphone application called AMPLIFY app that enables prescription and progression of exercises/functional activities, while offering immediate feedback on UL movement performed, real-time logging and monitoring of adherence through virtual platform. The inherent interactive nature of app offers features to engage and remind people with stroke to use their paretic UL. This app offers remote monitoring and supervision by therapists without need for actual therapists' physical presence. As the AMPLIFY app is a newly developed AI-powered interactive smartphone application, it is important to investigate the app's feasibility, usefulness in improving users' experience, effect on adherence, UL use, recovery and cost-effectiveness.
Aim:
To Investigate:
- Feasibility of AMPLIFY app in completing self-directed UL therapy programme
- Usefulness of AMPLIFY app in improving the users' experience in self-directed UL therapy programme performance
- Effectiveness of AMPLIFY app in increasing adherence in self-directed UL therapy programme performance
- Effectiveness of AMPLIFY app in increasing UL use, confidence and improving recovery after stroke
- Cost-effectiveness of AMPLIFY app in reducing the need for clinical review in self-directed UL therapy programme performance
Methods:
The study is a prospective randomized controlled trial (RCT) to compare the implementation of AMPLIFY programme in two modes of delivery- smartphone app versus hardcopy manuals to investigate the aims mentioned above.
People with stroke who fit into the inclusion and exclusion criteria will be invited to participate in the study via informed consent by the research assistant (RA)/ study team members. Once the informed consent has been given by the participants, the participants will undergo the pre-intervention assessment. After the pre-intervention assessment, the participants will be randomised either to the experimental group (AMPLIFY programme via the smartphone app) or control group (AMPLIFY programme via the hardcopy manuals). The intervention of experimental and control arms are described below. Both groups essentially undergo the same AMPLIFY programme but via different modes. Time points of assessment: pre-intervention, post-intervention and post-3months intervention assessments.
Experimental arm Assigned intervention The AMPLIFY Programme will be delivered via smartphone application with two levels. Level 1 is catered for people with stroke with Action Research Arm Test (ARAT) score <34, while Level 2 is catered for people with stroke with ARAT score >=34. Level 1 consists of six warm up exercises, six strengthening exercises and ten functional activities. Level 2 consists of three warm up exercises, four strengthening exercises, nine hand coordination and dexterity exercises, and ten functional activities. Five to six exercises (including at least one functional activity) 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/functional activities three sessions per day (i.e. morning, afternoon, evening) and for six days per week. In addition, the stroke participants are to use their paretic UL to perform the functional activities prescribed to them whenever needed throughout the day. The AMPLIFY programme will last for four weeks. If the stroke participants are discharged before the AMPLIFY programme ends, the participants will continue with the programme at home with the reviews being performed by the therapists via tele-rehabilitation. Frequency of reviews for the experimental group will be as follows: Week1 (2x); Week2 (1x); Week3 (x0); Week4 (x1).
Control arm Assigned intervention The 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. Booklet 1 consists of six warm up exercises, six strengthening exercises and ten functional activities. Booklet 2 consists of three warm up exercises, four strengthening exercises, nine hand coordination and dexterity exercises, and ten functional activities. Five to six exercises (including at least one functional activity) 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/functional activities three sessions per day (i.e. morning, afternoon, evening) and for six days per week. In addition, the stroke participants are to use their paretic UL to perform the functional activities prescribed to them whenever needed throughout the day. The AMPLIFY programme will last for four weeks. If the stroke participants are discharged before the AMPLIFY programme ends, the participants will continue with the programme 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).
- Conditions
- Stroke
- Being tested
- AMPLIFY Smartphone Application, Hardcopy Manual
- Keywords
- Upper Limb, Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLIFY Smartphone ApplicationOther
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
Hardcopy ManualOther
Hardcopy Manual
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Hardcopy Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from pre-intervention to immediate post-intervention
Secondary outcomes (18)
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)
Measured: Change from immediate post-intervention to 3 month post-intervention
Change in Upper Limb Self-Efficacy Test
Change in Upper Limb Self-Efficacy Test (minimum score 0 - maximum score 200; the higher the score the higher the level of self-efficacy in upper limb use)
Measured: Change from pre-intervention to immediate post-intervention
Change in Upper Limb Self-Efficacy Test
Change in Upper Limb Self-Efficacy Test (minimum score 0 - maximum score 200; the higher the score the higher the level of self-efficacy in upper limb use)
Measured: Change from immediate post-intervention to 3 month post-intervention
Change in Rating of Everyday Arm-use in the Community and Home
Change in Rating of Everyday Arm-use in the Community and Home (minimum score 0 -maximum score 5; the higher the score the higher the level of upper limb use)
Measured: Change from pre-intervention to immediate post-intervention
Change in Rating of Everyday Arm-use in the Community and Home
Change in Rating of Everyday Arm-use in the Community and Home (minimum score 0 -maximum score 5; the higher the score the higher the level of upper limb use)
Measured: Change from immediate post-intervention to 3 month post-intervention
Change in Stroke Rehabilitation Motivation Scale
Change in Stroke Rehabilitation Motivation Scale (minimum score 28 - maximum score 140; the higher the score the higher the level of motivation)
Measured: Change from pre-intervention to immediate post-intervention
Change in Stroke Rehabilitation Motivation Scale (SRMS)
Change in Stroke Rehabilitation Motivation Scale (minimum score 28 - maximum score 140; the higher the score the higher the level of motivation)
Measured: Change from immediate post-intervention to 3 month post-intervention
Change in upper limb pain visual analogue scale
Change in upper limb pain visual analogue scale (minimum score 0 - maximum score 10; the higher the score the higher the level of upper limb pain)
Measured: Change from pre-intervention to immediate post-intervention
Change in upper limb pain visual analogue scale
Change in upper limb pain visual analogue scale (minimum score 0 - maximum score 10; the higher the score the higher the level of upper limb pain)
Measured: Change from immediate post-intervention to 3 month post-intervention
Change in upper limb Modified Ashworth Scale
Change in upper limb Modified Ashworth Scale (minimum score 0 - maximum score 4; the higher the score the higher the level of upper limb resistance to passive movement)
Measured: Change from pre-intervention to immediate post-intervention
Change in upper limb Modified Ashworth Scale
Change in upper limb Modified Ashworth Scale (minimum score 0 - maximum score 4; the higher the score the higher the level of upper limb resistance to passive movement)
Measured: Change from immediate post-intervention to 3 month post-intervention
Feasibility - Number of drop-out
Number of drop-out from AMPLIFY Programme
Measured: Throughout the 4 weeks of intervention
Feasibility- Number of adverse events related to AMPLIFY Programme
Number of adverse events related to intervention
Measured: Throughout the 4 weeks of intervention
AMPLIFY Programme Adherence
Percentage of adherence to the prescribed AMPLIFY Programme
Measured: Throughout the 4 weeks of intervention
Number of upper limb repetitions performed in AMPLIFY Programme
Number of upper limb repetitions performed in AMPLIFY Programme
Measured: Throughout the 4 weeks of intervention
Number of Clinical Reviews in AMPLIFY Programme
Number of Clinical Reviews in AMPLIFY Programme
Measured: Throughout the 4 weeks of intervention
User Experience Survey
Feedback on user experience on hardcopy manual / smartphone application (minimum score 0 - maximum score 40; the higher the score the higher the ease and satisfaction to the use of the hardcopy manual / smartphone application)
Measured: End of 4 weeks intervention
Affinity for Technology Interaction Scale
Affinity for Technology Interaction Scale (minimum score 1 - maximum score 6; the higher the score the higher the affinity to technology)
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start11 Mar 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Blinded Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190795
- Sponsor's protocol ID
- 2023/00507
- Other IDs
- 2023
- Status last verified
- Aug 2024
- First submitted
- 19 Dec 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34281405
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of AI-powered Interactive Smartphone Application for a Self-directed Upper Limb Therapy Implementation After Stroke
- ClinicalTrials.gov ID
- NCT06190795
- Acronym / sponsor ID
- 2023/00507
- Conditions
- Stroke
- Keywords
- Upper Limb, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background To intensify practice to influence neuroplasticity to optimize UL recovery after stroke, it is important to empower people with stroke to perform self-directed UL therapy outside therapy. However, it has been found that increasing UL practice is often challenging with high level of inactivity found in people with stroke during rehabilitation. Traditionally, self-directed program has been delivered via hard copy manuals. Hardcopy manuals are often cumbersome and difficult to retrieve and handle, especially for those with moderate/severe UL impairment. Hence a more accessible format of exercise/activities instructions is needed. There is lack of reminders for people with stroke to keep up to prescribed exercise regime. This may affect adherence as some may not remember the prescribed practice sessions. Without immediate feedback of UL movement performed during self-practice, people with stroke may continue with compensatory movement performance without correction. This may in turns hinder UL recovery.
The aim of this study is to overcome these challenges by developing an AI-powered interactive smartphone application called AMPLIFY app that enables prescription and progression of exercises/functional activities, while offering immediate feedback on UL movement performed, real-time logging and monitoring of adherence through virtual platform. The inherent interactive nature of app offers features to engage and remind people with stroke to use their paretic UL. This app offers remote monitoring and supervision by therapists without need for actual therapists' physical presence. As the AMPLIFY app is a newly developed AI-powered interactive smartphone application, it is important to investigate the app's feasibility, usefulness in improving users' experience, effect on adherence, UL use, recovery and cost-effectiveness.
Aim:
To Investigate:
- Feasibility of AMPLIFY app in completing self-directed UL therapy programme
- Usefulness of AMPLIFY app in improving the users' experience in self-directed UL therapy programme performance
- Effectiveness of AMPLIFY app in increasing adherence in self-directed UL therapy programme performance
- Effectiveness of AMPLIFY app in increasing UL use, confidence and improving recovery after stroke
- Cost-effectiveness of AMPLIFY app in reducing the need for clinical review in self-directed UL therapy programme performance
Methods:
The study is a prospective randomized controlled trial (RCT) to compare the implementation of AMPLIFY programme in two modes of delivery- smartphone app versus hardcopy manuals to investigate the aims mentioned above.
People with stroke who fit into the inclusion and exclusion criteria will be invited to participate in the study via informed consent by the research assistant (RA)/ study team members. Once the informed consent has been given by the participants, the participants will undergo the pre-intervention assessment. After the pre-intervention assessment, the participants will be randomised either to the experimental group (AMPLIFY programme via the smartphone app) or control group (AMPLIFY programme via the hardcopy manuals). The intervention of experimental and control arms are described below. Both groups essentially undergo the same AMPLIFY programme but via different modes. Time points of assessment: pre-intervention, post-intervention and post-3months intervention assessments.
Experimental arm Assigned intervention The AMPLIFY Programme will be delivered via smartphone application with two levels. Level 1 is catered for people with stroke with Action Research Arm Test (ARAT) score <34, while Level 2 is catered for people with stroke with ARAT score >=34. Level 1 consists of six warm up exercises, six strengthening exercises and ten functional activities. Level 2 consists of three warm up exercises, four strengthening exercises, nine hand coordination and dexterity exercises, and ten functional activities. Five to six exercises (including at least one functional activity) 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/functional activities three sessions per day (i.e. morning, afternoon, evening) and for six days per week. In addition, the stroke participants are to use their paretic UL to perform the functional activities prescribed to them whenever needed throughout the day. The AMPLIFY programme will last for four weeks. If the stroke participants are discharged before the AMPLIFY programme ends, the participants will continue with the programme at home with the reviews being performed by the therapists via tele-rehabilitation. Frequency of reviews for the experimental group will be as follows: Week1 (2x); Week2 (1x); Week3 (x0); Week4 (x1).
Control arm Assigned intervention The 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. Booklet 1 consists of six warm up exercises, six strengthening exercises and ten functional activities. Booklet 2 consists of three warm up exercises, four strengthening exercises, nine hand coordination and dexterity exercises, and ten functional activities. Five to six exercises (including at least one functional activity) 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/functional activities three sessions per day (i.e. morning, afternoon, evening) and for six days per week. In addition, the stroke participants are to use their paretic UL to perform the functional activities prescribed to them whenever needed throughout the day. The AMPLIFY programme will last for four weeks. If the stroke participants are discharged before the AMPLIFY programme ends, the participants will continue with the programme 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Blinded Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application | Experimental | Other: AMPLIFY Smartphone ApplicationAMPLIFY 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). |
| Hardcopy Manual | Active comparator | Other: Hardcopy ManualAMPLIFY 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). |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLIFY Smartphone ApplicationAMPLIFY 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 | Other | Smartphone Application |
| Hardcopy ManualHardcopy Manual | Other | Hardcopy Manual |
Primary outcome
Change in Action Research Arm Test
Time frame: Change from pre-intervention to immediate post-intervention
Change in Action Research Arm Test (minimum score 0 - maximum score 57; the higher the score the better the upper limb performance)
18 secondary outcomes
Change in Action Research Arm Test
Time frame: Change from immediate post-intervention to 3 month post-intervention
Change in Upper Limb Self-Efficacy Test
Time frame: Change from pre-intervention to immediate post-intervention
Change in Upper Limb Self-Efficacy Test
Time frame: Change from immediate post-intervention to 3 month post-intervention
Change in Rating of Everyday Arm-use in the Community and Home
Time frame: Change from pre-intervention to immediate post-intervention
Change in Rating of Everyday Arm-use in the Community and Home
Time frame: Change from immediate post-intervention to 3 month post-intervention
Change in Stroke Rehabilitation Motivation Scale
Time frame: Change from pre-intervention to immediate post-intervention
Change in Stroke Rehabilitation Motivation Scale (SRMS)
Time frame: Change from immediate post-intervention to 3 month post-intervention
Change in upper limb pain visual analogue scale
Time frame: Change from pre-intervention to immediate post-intervention
Change in upper limb pain visual analogue scale
Time frame: Change from immediate post-intervention to 3 month post-intervention
Change in upper limb Modified Ashworth Scale
Time frame: Change from pre-intervention to immediate post-intervention
Change in upper limb Modified Ashworth Scale
Time frame: Change from immediate post-intervention to 3 month post-intervention
Feasibility - Number of drop-out
Time frame: Throughout the 4 weeks of intervention
Feasibility- Number of adverse events related to AMPLIFY Programme
Time frame: Throughout the 4 weeks of intervention
AMPLIFY Programme Adherence
Time frame: Throughout the 4 weeks of intervention
Number of upper limb repetitions performed in AMPLIFY Programme
Time frame: Throughout the 4 weeks of intervention
Number of Clinical Reviews in AMPLIFY Programme
Time frame: Throughout the 4 weeks of intervention
User Experience Survey
Time frame: End of 4 weeks intervention
Affinity for Technology Interaction Scale
Time frame: Pre-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 34281405Chin 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.
- pubmed link to journal articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLIFY Smartphone Application and Hardcopy Manual in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Action Research Arm Test (time frame: Change from pre-intervention to immediate post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06190795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.