StrokeNCT05673733
Additional Effects of Scapular Stabilization Exercise With Exergaming Training in Stroke Patients
A study testing scapular stabilization exercises with exergaming training and exergaming training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The World Health Organization has termed stroke to be a clinical syndrome, of presumed vascular origin, typified by rapidly developing signs of focal or global disturbance of cerebral functions and the leading cause of death worldwide in 2016 making it a major non-contagious cause of death. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- scapular stabilization exercises with exergaming training and exergaming training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2023to Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Stroke patients with an initial onset of 6 months or above.
- Those who had 30-65 points by Fugl-Meyer Assessment of upper extremity
- Those who had minimum score 24 on mini mental state examination
- Those who have the ability to execute at least 20' of active shoulder flexion and abduction against gravity those who could understand and follow instructions provided by the investigator
- Those who are medically stable enough to participate in active rehab
- Those who have no problems with auditory or visual functioning.
- Modified Ashworth Scale (MAS) 1-3
Who cannot join
- Orthopaedic or mental health problems
- Those who have difficulty to stay in a sitting position
- Severe conditions such as uncontrolled blood pressure or angina
- History of epilepsy
- The refusal to play a video game.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shumaila
Rawalpindi, 46000
Shumaila Kiran, MSNMPT*, 03348842139
About this study
Official title: Additional Effects of Scapular Stabilization Exercise With Exergaming Training on Upper Limb Functions in Chronic Stroke Patients
The World Health Organization has termed stroke to be a clinical syndrome, of presumed vascular origin, typified by rapidly developing signs of focal or global disturbance of cerebral functions and the leading cause of death worldwide in 2016 making it a major non-contagious cause of death. This study would be beneficial in a way that it will give a valuable input and will contribute for the knowledge of interventions for stroke with an emphasis on upper extremity function among health care practitioners for their goal of promoting health, prevention of diseases and improving quality of life.
Read the detailed description
Exergaming can contribute to improvement of the function of UE motor and AROM in chronic stroke patients, additional studies with a large number of subjects with long follow-up periods are required to determine their effectiveness neurorehabilitation stimulation . The exergaming protocol presented in this study represents success a tool for UE functional aspects in patients with chronic stroke. It has shown improvement in gripping strength, handicrafts and UE's operational recovery. Movement control and the position of scapula determine an optimal upper limb function. Paresis leading to scapular disorientation ultimately exaggerates motor impairment in upper extremities. Recent literature has emphasized on the need to design an upper extremity protocol including scapular stabilization exercises in order to increase muscular strength and decrease scapular dyskinesis .The results of a study showed that scapular stability exercises had an impact on hand function and the ability to move hemiplegic patients after stroke.
- Conditions
- Stroke
- Being tested
- scapular stabilization exercises with exergaming training, exergaming training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scapular stabilization exercises with exergaming trainingOther
Group A will receive scapular stabilization exercises with exergaming training
exergaming trainingOther
Group B will receive only exergaming training
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Exergaming training combined with Scapular stabilization exercises will be performed for 6 weeks for 3 times per week. Receives: Other: scapular stabilization exercises with exergaming training |
| Group B | Active comparator | Exergaming training will be performed for 6 weeks for 3 times per week. Receives: Other: exergaming training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment tool of Upper Extremity Function
To assess motor functioning, balance , sensation and joint functioning in patients with post-stroke hemiplegia.
Change from baseline and 2 months
Measured: 2 months
Wolf Motor Function Test
It quantifies upper extremity (UE) motor ability through timed and functional tasks. The items are rated on a 6-point scale.
Change from baseline and 2 months
Measured: 2 months
Jebsen Taylor Hand Function Test
It is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
- Scoring: The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated feeding, stacking, and lifting large, lightweight, and heavy objects. Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.
Change from baseline and 2 months
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start10 Jan 2023
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exergaming Training
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673733
- Sponsor's protocol ID
- Shumailakiran
- Status last verified
- Feb 2023
- First submitted
- 4 Jan 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Scapular Stabilization Exercise With Exergaming Training on Upper Limb Functions in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05673733
- Acronym / sponsor ID
- Shumailakiran
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Jan 2023 (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 World Health Organization has termed stroke to be a clinical syndrome, of presumed vascular origin, typified by rapidly developing signs of focal or global disturbance of cerebral functions and the leading cause of death worldwide in 2016 making it a major non-contagious cause of death. This study would be beneficial in a way that it will give a valuable input and will contribute for the knowledge of interventions for stroke with an emphasis on upper extremity function among health care practitioners for their goal of promoting health, prevention of diseases and improving quality of life.
Detailed description
Exergaming can contribute to improvement of the function of UE motor and AROM in chronic stroke patients, additional studies with a large number of subjects with long follow-up periods are required to determine their effectiveness neurorehabilitation stimulation . The exergaming protocol presented in this study represents success a tool for UE functional aspects in patients with chronic stroke. It has shown improvement in gripping strength, handicrafts and UE's operational recovery. Movement control and the position of scapula determine an optimal upper limb function. Paresis leading to scapular disorientation ultimately exaggerates motor impairment in upper extremities. Recent literature has emphasized on the need to design an upper extremity protocol including scapular stabilization exercises in order to increase muscular strength and decrease scapular dyskinesis .The results of a study showed that scapular stability exercises had an impact on hand function and the ability to move hemiplegic patients after stroke.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Exergaming Training
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: scapular stabilization exercises with exergaming trainingExergaming training combined with Scapular stabilization exercises will be performed for 6 weeks for 3 times per week. |
| Group B | Active comparator | Other: exergaming trainingExergaming training will be performed for 6 weeks for 3 times per week. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic Stroke patients with an initial onset of 6 months or above.
- Those who had 30-65 points by Fugl-Meyer Assessment of upper extremity
- Those who had minimum score 24 on mini mental state examination
- Those who have the ability to execute at least 20' of active shoulder flexion and abduction against gravity those who could understand and follow instructions provided by the investigator
- Those who are medically stable enough to participate in active rehab
Key exclusion criteria (5 listed)
- Orthopaedic or mental health problems
- Those who have difficulty to stay in a sitting position
- Severe conditions such as uncontrolled blood pressure or angina
- History of epilepsy
- The refusal to play a video game.
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 |
|---|---|---|
| scapular stabilization exercises with exergaming trainingGroup A will receive scapular stabilization exercises with exergaming training | Other | Group A |
| exergaming trainingGroup B will receive only exergaming training | Other | Group B |
Primary outcome
Fugl-Meyer Assessment tool of Upper Extremity Function
Time frame: 2 months
To assess motor functioning, balance , sensation and joint functioning in patients with post-stroke hemiplegia. Change from baseline and 2 months
Wolf Motor Function Test
Time frame: 2 months
It quantifies upper extremity (UE) motor ability through timed and functional tasks. The items are rated on a 6-point scale. Change from baseline and 2 months
Jebsen Taylor Hand Function Test
Time frame: 2 months
It is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). - Scoring: The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated feeding, stacking, and lifting large, lightweight, and heavy objects. Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance. Change from baseline and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Misbah Ghous, 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 scapular stabilization exercises with exergaming training and exergaming training in people with Stroke, 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 5 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Misbah Ghous, MSNMPT (03345695456, misbah.ghous@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment tool of Upper Extremity Function (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2023.