Infected JointNCT06437015
Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions
A study testing Constraint-Induced Movement Therapy and Mirror Therapy in people with Infected Joint, run by Superior University at 1 site in Pakistan.
Trial summary
CIMT vs Mirror therapy for improving hand function in infarcted CVA patients. Randomized clinical trial study design will be followed. Data will be collected from following centers: Minhaj Physiotherapy Centre, Home visits, Sughra sidiq trust hospital, Ibad hospital Samundri. Probability Random Sampling is used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infected Joint
- What is being tested?
- Constraint-Induced Movement Therapy and Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 29 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infarcted CVA patients
- Patients with hand improvement needed
- Patients in recovery stage of stroke from 2 months to 1 year
- Patients who can participate in 45 mins of session
Who cannot join
- Patients with hand function disturbed due to any other reason except infarcted CVA, - - - Patients with shoulder subluxation and upper limb contractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Minhaj Physiotherapy, opp Shalimar Hospital , Shalimar
Lahore, Punjab Province
About this study
CIMT vs Mirror therapy for improving hand function in infarcted CVA patients. Randomized clinical trial study design will be followed. Data will be collected from following centers: Minhaj Physiotherapy Centre, Home visits, Sughra sidiq trust hospital, Ibad hospital Samundri. Probability Random Sampling is used.
- Conditions
- Infected Joint
- Being tested
- Constraint-Induced Movement Therapy, Mirror Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement TherapyDiagnostic test
patient's unaffected hand is tied with a triangular bandage or splint and the patient asks to perform the exercise through the affected hand. for up to 6 hours a day for 5days week /4 weeks and the patient nonparetic arm restrained from the use by having the patient placing a mitt on the hand or a sling on the unaffected hand, forcing the use of the affected limb to promote purposeful movements when performing functional tasks.
Mirror TherapyOther
In this group training was given for 45min a day for 5 days a week for 4 weeks. Mirror box which was of 18×24inch [was placed on the learning table and exercises were carried out by the patient looking into the mirror where an unaffected limb is placed in front of the mirror, through looking into the mirror patient assumes the reflection of the unaffected limb as the paretic limb. Exercises performed were hand opening and closing, wrist extension and flexion, squeezing, opposition, the calculation
| Study group | Role | What they receive |
|---|---|---|
| Constraint-Induced Movement Therapy | Experimental | Not described Receives: Diagnostic Test: Constraint-Induced Movement Therapy |
| Mirror Therapy | Active comparator | Not described Receives: Other: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Assessment (FMA)
it is a stroke-specific, performance-based impairment index.Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully
Measured: 12 Months
The Chedoke Arm and Hand Activity Inventory (CAHAI)
It is used to assess functional ability of the paretic arm and hand. This test consists of 13 functional tasks: open a jar of coffee, draw a line with a ruler, put toothpaste on a toothbrush, cut medium consistency putty,pour a glass of water wring out a washcloth,clean a pair of eyeglasses,zip up a zipper,botton up 5 buttons,dry back with a towel,place a container on a table and carry a bag up the stairs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Nov 2023
- Primary completion20 May 2024
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected JointStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437015
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/720
- Status last verified
- May 2024
- First submitted
- 25 May 2024
- Last updated
- 31 May 2024
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions
- ClinicalTrials.gov ID
- NCT06437015
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/720
- Conditions
- Infected Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 31 May 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.
CIMT vs Mirror therapy for improving hand function in infarcted CVA patients. Randomized clinical trial study design will be followed. Data will be collected from following centers: Minhaj Physiotherapy Centre, Home visits, Sughra sidiq trust hospital, Ibad hospital Samundri. Probability Random Sampling is used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-Induced Movement Therapy | Experimental | Diagnostic Test: Constraint-Induced Movement Therapy |
| Mirror Therapy | Active comparator | Other: Mirror Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infarcted CVA patients
- Patients with hand improvement needed
- Patients in recovery stage of stroke from 2 months to 1 year
- Patients who can participate in 45 mins of session
Key exclusion criteria (1 listed)
- Patients with hand function disturbed due to any other reason except infarcted CVA, - - - Patients with shoulder subluxation and upper limb contractures
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 |
|---|---|---|
| Constraint-Induced Movement Therapypatient's unaffected hand is tied with a triangular bandage or splint and the patient asks to perform the exercise through the affected hand. for up to 6 hours a day for 5days week /4 weeks and the patient nonparetic arm restrained from the use by having the patient placing a mitt on the hand or a sling on the unaffected hand, forcing the use of the affected limb to promote purposeful movements when performing functional tasks. | Diagnostic test | Constraint-Induced Movement Therapy |
| Mirror TherapyIn this group training was given for 45min a day for 5 days a week for 4 weeks. Mirror box which was of 18×24inch [was placed on the learning table and exercises were carried out by the patient looking into the mirror where an unaffected limb is placed in front of the mirror, through looking into the mirror patient assumes the reflection of the unaffected limb as the paretic limb. Exercises performed were hand opening and closing, wrist extension and flexion, squeezing, opposition, the calculation | Other | Mirror Therapy |
Primary outcome
The Fugl-Meyer Assessment (FMA)
Time frame: 12 Months
it is a stroke-specific, performance-based impairment index.Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully
The Chedoke Arm and Hand Activity Inventory (CAHAI)
Time frame: 12 months
It is used to assess functional ability of the paretic arm and hand. This test consists of 13 functional tasks: open a jar of coffee, draw a line with a ruler, put toothpaste on a toothbrush, cut medium consistency putty,pour a glass of water wring out a washcloth,clean a pair of eyeglasses,zip up a zipper,botton up 5 buttons,dry back with a towel,place a container on a table and carry a bag up the stairs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
Related trials for Infected Joint
Recruiting
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
Periprosthetic Joint Infections
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 Constraint-Induced Movement Therapy and Mirror Therapy in people with Infected Joint, run by Superior 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 1 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 31 May 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?
Results are not available in the source record.
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 Fugl-Meyer Assessment (FMA) (time frame: 12 Months). The study lists 2 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 31 May 2024.