Chronic Stroke PatientsNCT06696885
Mobile Applications for Exercise Adherence and Hand Function in Chronic Stroke.
A study testing Mobile based video games and task based training in people with Chronic Stroke Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is a clinically defined syndrome characterized by an acute, focal neurological deficit due to vascular damage in the central nervous system. It is the second leading cause of death and disability globally. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- Mobile based video games and task based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jan 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age 30 to 75 years were included.
- Chronic stroke patients ranging from 6 months to 2 years (41).
- Participants having a stroke severity score > 6 on National Institute of Health Stroke Scale (NIHSS) (42).
- Modified Ashworth scale score ≤ 3 of the affected upper extremity (44).
- Montreal Cognitive Assessment (MoCA) score ≥ 26 (45).
- Patients who are able to sit without support.
- No contractures of the affected wrist and fingers.
Who cannot join
- Participants who show the symptoms of global or receptive aphasia.
- Participants who have medical problems or co-morbidities that interdict their participation in the study (such as shoulder pain in the paretic limb).
- Patients with severe apraxia, somatosensory problems.
- Severe spasticity of the affected wrist and finger flexors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54770
Binash Afzal, PhD, +923434539092, binash.afzal@riphah.edu.pk
About this study
Official title: Combined Effects of Mobile Based Video Games and Face to Face Exercise Program on Exercise Adherence and Hand Function in Chronic Stroke.
Stroke is a clinically defined syndrome characterized by an acute, focal neurological deficit due to vascular damage in the central nervous system. It is the second leading cause of death and disability globally. Stroke is not a singular disease but results from a variety of risk factors, disease processes, and mechanisms. Following a stroke, upper limb (UL) dysfunction affects 40-50% of individuals in the chronic phase, significantly impacting their ability to perform daily tasks. The latest trend in therapy involves the use of mobile video games within rehabilitation programs. These applications leverage the multi-touch interface of mobile devices to provide accurate monitoring of a patient's health status. Many of these mobile games are specifically designed to offer therapeutic tools that enhance dexterity and improve adherence to exercise routines.
Read the detailed description
A Randomized Clinical Trail (RCT) design will be employed, conducted at Johar Pain Relief center over 10 months following the synopsis approval. The anticipated sample size, accounting for a 20% attrition rate will be 32 participants in each of the study groups. Group A will recieve mobile based video games along with task based therapy for exercise adherence and hand function while Group B will recieve conventional physical therapy. The sampling technique will be non probability convenience sampling with inclusion criteria of including chronic stroke patients aged between 30 to 75 years, both male and female genders are included in the study. The data collection tools include National Institute of Health Stroke Scale (NIHSS) , Fugl Meyer Assessment -UE (FM-UE) , Game User Experience Satisfaction Scale (GUESS) , Exercise Adherence Rating Scale (Ears) and Box and Block test was applied. The analysis will be conducted using SPSS for windows software version 25. Training session will last for 6 weeks which will be conducted 6 days a week. Mobile based video games and task based training will focus on exercise adherence and hand function, mainly focusing on hand dexterity.
- Conditions
- Chronic Stroke Patients
- Being tested
- Mobile based video games and task based training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile based video games and task based trainingOther
The experimental group received a mobile-based applications for 20 minutes and tasks-based training for 20 minutes per day (a total of 40 minutes), 6 days a week for 17 weeks. The time between each game was divided accordingly to work on improving hand function. The games and tasks were divided into three broad categories, Easy, Moderate, Difficult. Each category is applied for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received mobile based video games along with task based training. Receives: Other: Mobile based video games and task based training |
| Group B | No intervention | Group B received conventional physical therapy plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Fugl Meyer Assessment -UE (FM-UE)
FMA(UE) is a assessment tool for upper extremity which is divided into 5 domains (motor, sensory, balance, range of motion, and pain)
Measured: 6 weeks
Game User Experience Satisfaction Scale (GUESS)
GUESS evaluates patient satisfaction of video-games following their participation in the gamified intervention. The GUESS consists of 55 items with 9 subscales. The subscales include usability/playability, narratives, play engrossment, enjoyment, creative freedom, audio aesthetics, personal gratification, social connectivity and visual aesthetics.
Measured: 6 weeks
Exercise Adherence Rating Scale (EARS)
EARS is a tool designed to assess an individual's commitment to a prescribed exercise program.
Measured: 6 weeks
Box and Block Test (BBT)
Box and Block Test (BBT) measures manual dexterity by counting how many blocks a participant can transfer between compartments in 60 seconds
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start12 Jan 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
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 Chronic Stroke PatientsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binish Afzal, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696885
- Sponsor's protocol ID
- REC/RCR & AHS/24/0205
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sulfikar Ali A, Arumugam A, Kumaran D S. Effectiveness of an intensive, functional, gamified Rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the EnteRtain randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106381. doi: 10.1016/j.cct.2021.106381. Epub 2021 Apr 20.
PubMed 33862286
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Mobile Based Video Games and Face to Face Exercise Program on Exercise Adherence and Hand Function in Chronic Stroke.
- ClinicalTrials.gov ID
- NCT06696885
- Acronym / sponsor ID
- REC/RCR & AHS/24/0205
- Conditions
- Chronic Stroke Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 20 Nov 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.
Stroke is a clinically defined syndrome characterized by an acute, focal neurological deficit due to vascular damage in the central nervous system. It is the second leading cause of death and disability globally. Stroke is not a singular disease but results from a variety of risk factors, disease processes, and mechanisms. Following a stroke, upper limb (UL) dysfunction affects 40-50% of individuals in the chronic phase, significantly impacting their ability to perform daily tasks. The latest trend in therapy involves the use of mobile video games within rehabilitation programs. These applications leverage the multi-touch interface of mobile devices to provide accurate monitoring of a patient's health status. Many of these mobile games are specifically designed to offer therapeutic tools that enhance dexterity and improve adherence to exercise routines.
Detailed description
A Randomized Clinical Trail (RCT) design will be employed, conducted at Johar Pain Relief center over 10 months following the synopsis approval. The anticipated sample size, accounting for a 20% attrition rate will be 32 participants in each of the study groups. Group A will recieve mobile based video games along with task based therapy for exercise adherence and hand function while Group B will recieve conventional physical therapy. The sampling technique will be non probability convenience sampling with inclusion criteria of including chronic stroke patients aged between 30 to 75 years, both male and female genders are included in the study. The data collection tools include National Institute of Health Stroke Scale (NIHSS) , Fugl Meyer Assessment -UE (FM-UE) , Game User Experience Satisfaction Scale (GUESS) , Exercise Adherence Rating Scale (Ears) and Box and Block test was applied. The analysis will be conducted using SPSS for windows software version 25. Training session will last for 6 weeks which will be conducted 6 days a week. Mobile based video games and task based training will focus on exercise adherence and hand function, mainly focusing on hand dexterity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Mobile based video games and task based trainingGroup A received mobile based video games along with task based training. |
| Group B | No intervention | –Group B received conventional physical therapy plan. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients age 30 to 75 years were included.
- Chronic stroke patients ranging from 6 months to 2 years (41).
- Participants having a stroke severity score > 6 on National Institute of Health Stroke Scale (NIHSS) (42).
- Modified Ashworth scale score ≤ 3 of the affected upper extremity (44).
- Montreal Cognitive Assessment (MoCA) score ≥ 26 (45).
Key exclusion criteria (4 listed)
- Participants who show the symptoms of global or receptive aphasia.
- Participants who have medical problems or co-morbidities that interdict their participation in the study (such as shoulder pain in the paretic limb).
- Patients with severe apraxia, somatosensory problems.
- Severe spasticity of the affected wrist and finger flexors.
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 |
|---|---|---|
| Mobile based video games and task based trainingThe experimental group received a mobile-based applications for 20 minutes and tasks-based training for 20 minutes per day (a total of 40 minutes), 6 days a week for 17 weeks. The time between each game was divided accordingly to work on improving hand function. The games and tasks were divided into three broad categories, Easy, Moderate, Difficult. Each category is applied for 6 weeks | Other | Group A |
Primary outcome
• Fugl Meyer Assessment -UE (FM-UE)
Time frame: 6 weeks
FMA(UE) is a assessment tool for upper extremity which is divided into 5 domains (motor, sensory, balance, range of motion, and pain)
Game User Experience Satisfaction Scale (GUESS)
Time frame: 6 weeks
GUESS evaluates patient satisfaction of video-games following their participation in the gamified intervention. The GUESS consists of 55 items with 9 subscales. The subscales include usability/playability, narratives, play engrossment, enjoyment, creative freedom, audio aesthetics, personal gratification, social connectivity and visual aesthetics.
Exercise Adherence Rating Scale (EARS)
Time frame: 6 weeks
EARS is a tool designed to assess an individual's commitment to a prescribed exercise program.
Box and Block Test (BBT)
Time frame: 6 weeks
Box and Block Test (BBT) measures manual dexterity by counting how many blocks a participant can transfer between compartments in 60 seconds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 33862286Sulfikar Ali A, Arumugam A, Kumaran D S. Effectiveness of an intensive, functional, gamified Rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the EnteRtain randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106381. doi: 10.1016/j.cct.2021.106381. Epub 2021 Apr 20.
- 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.
Binish Afzal, MS-NMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile based video games and task based training in people with Chronic Stroke Patients, run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maira Sohail, MS- NMPT (+923244009200, mairasohail01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Fugl Meyer Assessment -UE (FM-UE) (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT06696885, 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 20 Nov 2024.