Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190795
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-19
Brief Title:
A Smartphone Application for a Self-directed Upper Limb Therapy After Stroke
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
Feasibility and Effectiveness of AI-powered Interactive Smartphone Application for a Self-directed Upper Limb Therapy Implementation After Stroke
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of study is to investigate a newly developed AI smartphone applications 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 moderatesevere UL impairment Hence a more accessible format of exerciseactivities 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 exercisesfunctional 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 apps feasibility usefulness in improving users experience effect on adherence UL use recovery and cost-effectiveness
Aim
To Investigate
1 Feasibility of AMPLIFY app in completing self-directed UL therapy programme
2 Usefulness of AMPLIFY app in improving the users experience in self-directed UL therapy programme performance
3 Effectiveness of AMPLIFY app in increasing adherence in self-directed UL therapy programme performance
4 Effectiveness of AMPLIFY app in increasing UL use confidence and improving recovery after stroke
5 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 exercisesfunctional activities three sessions per day ie 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 exercisesfunctional activities three sessions per day ie 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
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 exercisesfunctional 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 apps feasibility usefulness in improving users experience effect on adherence UL use recovery and cost-effectiveness
Aim
To Investigate
1 Feasibility of AMPLIFY app in completing self-directed UL therapy programme
2 Usefulness of AMPLIFY app in improving the users experience in self-directed UL therapy programme performance
3 Effectiveness of AMPLIFY app in increasing adherence in self-directed UL therapy programme performance
4 Effectiveness of AMPLIFY app in increasing UL use confidence and improving recovery after stroke
5 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 exercisesfunctional activities three sessions per day ie 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 exercisesfunctional activities three sessions per day ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None