Stroke, IschemicNCT05490797
Effects of Mobile Application Dexteria Fine Motor Skills on Hand Dexterity and Grip Strength in Chronic Stroke Patients
A study testing app based training with conventional therapy and conventional therapy in people with Stroke, Ischemic and Skill, Social, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Ischemic, Skill, Social, Occlusion
- What is being tested?
- app based training with conventional therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 20 Aug 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Six months to 2 years post stroke
- Participants must be able to open and close their fingers (even only 2 cm of movement)
- Before stroke there must be fully functional hand
- Normal or intact vision
Who cannot join
- Neurological disorders other than stroke for example multiple sclerosis or Parkinson disease.
- Upper extremities acute orthopaedic conditions.
- Any cardiopulmonary complications
- Medically unstable patients.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients
Read the detailed description
This study will be conducted to investigate the effects of mobile applications of dexterity fine motor skills on hand dexterity and grip strength in chronic stroke patients. Data will be collected from Jinnah hospital Lahore and Riphah Rehabilitation center Lahore. All 22 patients will be taken using random sampling. Both study groups will be given common treatment of conventional hand function. The subjects will randomly assign to the experiment group with mobile apps training and the control group without mobile app training. Mobile applications like Dexteria, ScribbleKid, PegLight and Bowling game will be used for the purpose of training and success rate will be considered as outcome measure. Test and tools include the Nine Hole Peg Test (NHPT), the Fugl-Meyer Motor assessment (FMA), The Box \& Block Test (BBT), and Grip strength will be assessed using a hand dynamometer. SPSS 25 version will be used for data entry and analysis.
- Conditions
- Stroke, Ischemic, Skill, Social, Occlusion
- Being tested
- app based training with conventional therapy, conventional therapy
- Keywords
- Stroke, Ischemic, Skill, Social, Occlusion
- Medical subject headings
- Ischemic Stroke, Social Skills, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app based training with conventional therapyOther
The experimental group will receive an additional mobile application therapy including , dexterity fine motor skills, bowling game, scribble game and peglight game in addition to the conventional therapy for hand function.
conventional therapyOther
conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise)
| Study group | Role | What they receive |
|---|---|---|
| app based training with conventional therapy | Experimental | In experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy. Receives: Other: app based training with conventional therapy |
| conventional therapy | Active comparator | The control group will receive conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise) Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nine Hole Peg Test (NHPT)
The Nine Hole Peg Test (NHPT) is designed to quantify finger dexterity with neurological diagnoses patients.
Measured: 9 months
Fugl-Meyer Motor assessment (FMA)
Fugl-Meyer Motor assessment (FMA) is specific for post stroke performance based on impairment index. This is specific for quantification of balance and motor functioning.
Measured: 9 months
The Box &Block Test (BBT)
The Box \&Block Test (BBT) is designed for measuring overall manual dexterity.
Measured: 9 months
hand dynamometer.
Grip strength is assessed using a hand dynamometer.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jan 2022
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- total 22 participants will be enrolled. In experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy. Conventional hand therapy will be given to the second group.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490797
- Sponsor's protocol ID
- REC/RCR & AHS/21/0255
- Status last verified
- Nov 2022
- First submitted
- 4 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lanas F, Seron P. Facing the stroke burden worldwide. Lancet Glob Health. 2021 Mar;9(3):e235-e236. doi: 10.1016/S2214-109X(20)30520-9. Epub 2021 Jan 7. No abstract available.
PubMed 33422188Doumas I, Everard G, Dehem S, Lejeune T. Serious games for upper limb rehabilitation after stroke: a meta-analysis. J Neuroeng Rehabil. 2021 Jun 15;18(1):100. doi: 10.1186/s12984-021-00889-1.
PubMed 34130713Olsen TS. Arm and leg paresis as outcome predictors in stroke rehabilitation. Stroke. 1990 Feb;21(2):247-51. doi: 10.1161/01.str.21.2.247.
PubMed 2305400Jensen M, Thomalla G. Causes and Secondary Prevention of Acute Ischemic Stroke in Adults. Hamostaseologie. 2020 Feb;40(1):22-30. doi: 10.1055/s-0039-1700502. Epub 2019 Oct 24.
PubMed 31648355
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobile Application Dexteria Fine Motor Skills on Hand Dexterity and Grip Strength in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05490797
- Acronym / sponsor ID
- REC/RCR & AHS/21/0255
- Conditions
- Stroke, Ischemic, Skill, Social, Occlusion
- Keywords
- Stroke, Ischemic, Skill, Social, Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 8 Aug 2022 (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.
To determine the effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients
Detailed description
This study will be conducted to investigate the effects of mobile applications of dexterity fine motor skills on hand dexterity and grip strength in chronic stroke patients. Data will be collected from Jinnah hospital Lahore and Riphah Rehabilitation center Lahore. All 22 patients will be taken using random sampling. Both study groups will be given common treatment of conventional hand function. The subjects will randomly assign to the experiment group with mobile apps training and the control group without mobile app training. Mobile applications like Dexteria, ScribbleKid, PegLight and Bowling game will be used for the purpose of training and success rate will be considered as outcome measure. Test and tools include the Nine Hole Peg Test (NHPT), the Fugl-Meyer Motor assessment (FMA), The Box \& Block Test (BBT), and Grip strength will be assessed using a hand dynamometer. SPSS 25 version will be used for data entry and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- total 22 participants will be enrolled. In experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy. Conventional hand therapy will be given to the second group.
| Arm | Type | Receives |
|---|---|---|
| app based training with conventional therapy | Experimental | Other: app based training with conventional therapyIn experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy. |
| conventional therapy | Active comparator | Other: conventional therapyThe control group will receive conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Six months to 2 years post stroke
- Participants must be able to open and close their fingers (even only 2 cm of movement)
- Before stroke there must be fully functional hand
- Normal or intact vision
Key exclusion criteria (4 listed)
- Neurological disorders other than stroke for example multiple sclerosis or Parkinson disease.
- Upper extremities acute orthopaedic conditions.
- Any cardiopulmonary complications
- Medically unstable patients.
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 |
|---|---|---|
| app based training with conventional therapyThe experimental group will receive an additional mobile application therapy including , dexterity fine motor skills, bowling game, scribble game and peglight game in addition to the conventional therapy for hand function. | Other | app based training with conventional therapy |
| conventional therapyconventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise) | Other | conventional therapy |
Primary outcome
The Nine Hole Peg Test (NHPT)
Time frame: 9 months
The Nine Hole Peg Test (NHPT) is designed to quantify finger dexterity with neurological diagnoses patients.
Fugl-Meyer Motor assessment (FMA)
Time frame: 9 months
Fugl-Meyer Motor assessment (FMA) is specific for post stroke performance based on impairment index. This is specific for quantification of balance and motor functioning.
The Box &Block Test (BBT)
Time frame: 9 months
The Box \&Block Test (BBT) is designed for measuring overall manual dexterity.
hand dynamometer.
Time frame: 9 months
Grip strength is assessed using a hand dynamometer.
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 9 Nov 2022.
- Background: PubMed 33422188Lanas F, Seron P. Facing the stroke burden worldwide. Lancet Glob Health. 2021 Mar;9(3):e235-e236. doi: 10.1016/S2214-109X(20)30520-9. Epub 2021 Jan 7. No abstract available.
- Background: PubMed 34130713Doumas I, Everard G, Dehem S, Lejeune T. Serious games for upper limb rehabilitation after stroke: a meta-analysis. J Neuroeng Rehabil. 2021 Jun 15;18(1):100. doi: 10.1186/s12984-021-00889-1.
- Background: PubMed 2305400Olsen TS. Arm and leg paresis as outcome predictors in stroke rehabilitation. Stroke. 1990 Feb;21(2):247-51. doi: 10.1161/01.str.21.2.247.
- Background: PubMed 31648355Jensen M, Thomalla G. Causes and Secondary Prevention of Acute Ischemic Stroke in Adults. Hamostaseologie. 2020 Feb;40(1):22-30. doi: 10.1055/s-0039-1700502. Epub 2019 Oct 24.
- 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.
zeest hashmi, MSNMPT 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 app based training with conventional therapy and conventional therapy in people with Stroke, Ischemic and Skill, Social, 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 4 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: finished, as of the sponsor's last update on 9 Nov 2022. 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?
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?
The Nine Hole Peg Test (NHPT) (time frame: 9 months). 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 NCT05490797, which also lists 4 linked publications.
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 9 Nov 2022.