StrokeNCT06625294
Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
A study testing Task -oriented training with bilateral functional task training exercises and Task Oriented Training with CIMT in people with Stroke and Hand Function, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Task-oriented training is an approach that will encourage active participation of the patient making treatment functional and task orientated in order to achieve the best possible recovery following injury. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Hand Function
- What is being tested?
- Task -oriented training with bilateral functional task training exercises and Task Oriented Training with CIMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 20 Dec 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.
- Age range from 40 to 60 years.
- Diagnosed Cases of Stroke.
- MMT greater than Grade 2.
- Wrist ROM valid for functional tasks.
- Brunnstrom stages of recovery: Grade 4
Show all 12Show fewer
- MAS: Grade 2 or less Exclusion Criteria
- Active joint disease (rheumatoid, or any other rheumatological disease)
- Recent history of upper limb surgery.
- Contractures or Deformity.
- Inability to follow-2-step commands.
- Psychiatric diagnoses.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Thrapy
Islamabad, 44000
About this study
Task-oriented training is an approach that will encourage active participation of the patient making treatment functional and task orientated in order to achieve the best possible recovery following injury.
Neurorehabilitation studies have shown that Constrained induced movement therapy can increase both motor function and the use of the paretic arm and that these improvements parallel changes in the activation of the brain sensorimotor network.
Bilateral Functional Task Training which promotes the use of the paretic limb simultaneously with the nonparetic limb. Many of our daily chores are bimanual and utilize concurrent use of both arms.
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effects of constraint induced movement therapy post-stroke patients with motor impairment of hand in terms of grasp/grip, pinch and gross movements.
- To determine the effects of bilateral functional task training post-stroke patients with motor impairment of hand in terms of grasp/grip, pinch and gross movements.
- To determine the comparative effects of constraint, induced movement therapy versus bilateral functional task training post-stroke patients with motor impairment of hand in terms of grasp/grip, pinch and gross movements.
HYPOTHESIS:
Alternate Hypothesis:
- There will be significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of grasp/grip p\<0.05
- There will be significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of pinch and gross movements. p\<0.05
Null Hypothesis:
- There will be no significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of grasp/grip p\<0.05
- There will be no significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of pinch and gross movements. p\<0.05
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Neuromedicine Department,Neurology OPD,Rehab OPD, Multidisciplinary Lab in FUCP, Fauji Foundation Hospital and Treatment room FUCP.
Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- Both genders.
- Age range from 40 to 60years.
- Diagnosed Cases of Stroke.
- MMT greater than Grade 2.
- Wrist ROM valid for functional tasks.
- Brunnstrom stages of recovery: Grade 4
- MAS: Grade 2 or less
Exclusion Criteria
- Active joint disease (rheumatoid, or any other rheumatological disease)
- Recent history of upper limb surgery.
- Contractures or Deformity.
- Inability to follow-2-step commands.
- Psychiatric diagnoses.
Technique: Convenience Sampling
Outcome Measures:
Data will be collected on Demographics and general information. Data will be collected using Action research arm test,Fugl-Meyer Assessment Upper Extremity (FMA-UE),Goniometry.
Experimental Group (A) = This group will receive task oriented training with bilateral functional task training and their outcomes will be measured at baseline and at the end of 10 weeks treatment..
Control group (B) =This group will undergo task oriented training with Constrained Induced Movement Therapy and their outcomes will be observed at the baseline and then after treatment of 10 weeks.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.
A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
- Task oriented training program including Constraint Induced movement therapy and Bilateral Functional Task Training for the restoration and improvement of the hand function in patients with stroke will prove effective in increasing strength and improving function along with grasp /grip pinch and gross movements.
- This study will help the practitioner to use the new treatment comparison options for treating patient's hand function improvement in stroke.
- The results of the study will add to the literature about the comparative effects of Constraint Induced movement therapy and Bilateral Functional Task Training in improving hand function in stroke patients.
- Conditions
- Stroke, Hand Function
- Being tested
- Task -oriented training with bilateral functional task training exercises, Task Oriented Training with CIMT
- Keywords
- Task Oriented Training, Constraint-Induced Movement Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task -oriented training with bilateral functional task training exercisesProcedure or surgery
Task oriented training approach with BFTT will consists of different tasks including:
Hand Movements:
- Fold a small cloth towel with both hands with initially putting the towel flat on the table and gradually folding it into a large towel roll.
- Put a small amount of putty on patient's table and instruct to roll it with the help of rolling pin moving it back and forth using both the hands.
- Place a jar with a removable lid on the table and instruct the patient to remove lid from the jar completely by holding the jar with either hand and remove the lid with the alternate hand.
- Pouring water: Pour water from jug while holding the jug in unaffected hand to cup/glass that is held in affected hand and activity can be done the other way round as well.
- Pour water from one hard plastic cup to another while alternatively involving both the hands (we must not allow deformation of the cup)
- Plunging action with coffee maker against water resistance:Fill the coffee maker with water.
Task Oriented Training with CIMTProcedure or surgery
- Hand Movements:
- Sitting at a table (Wrist Extension): Affected forearm resting on table. Place cylindrical object in palm of patient's hand. Patient asked to move the hand towards the forearm (dorsiflexion) by extending the wrist - no elbow flexion allowed.
- Sitting at a table (Radial Deviation of Wrist): Therapist should place forearm with ulnar side on table in mid-pronation / supination position. Thumb in line with forearm and wrist in extension. Fingers around cylindrical object. Patient is asked to lift hand off table. No wrist flexion or extension.
Advanced Hand Activities:
- Have the patient reach forward to pick up the top of a pen with their affected hand, bring the affected arm back to their side and put the pen cap down in front of them.
- Place (beans), in a teacup an arm's length away on the affected side. Place another teacup an arm's length away on the intact side. Have the patient pick up one beans with their affected hand and place the beans in the cup on the
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A | Experimental | It includes participants receiving task oriented combined with bilateral functional task training exercises for 10 weeks treatment. Receives: Procedure: Task -oriented training with bilateral functional task training exercises |
| Experimental group B | Experimental | This group involves participants receiving task oriented training with constrained induced movement therapy exercises for a period of 10 weeks. Receives: Procedure: Task Oriented Training with CIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity performance
Action Research Arm Test (ARAT) will be used for estimation of upper-limb function. This is a summated rating scale with 4 domains: Grasp, Grip, Pinch, and Gross. Scoring is based on the performance of several tasks from each domain. Each task is rated from 0 to 3, where higher scores denote less disability.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start20 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion20 Dec 2024 (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 Foundation University IslamabadThe 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
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Zahid, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625294
- Sponsor's protocol ID
- FUI/CTR/2024/32
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
- ClinicalTrials.gov ID
- NCT06625294
- Acronym / sponsor ID
- FUI/CTR/2024/32
- Conditions
- Stroke, Hand Function
- Keywords
- Task Oriented Training, Constraint-Induced Movement Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 3 Oct 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.
Task-oriented training is an approach that will encourage active participation of the patient making treatment functional and task orientated in order to achieve the best possible recovery following injury.
Neurorehabilitation studies have shown that Constrained induced movement therapy can increase both motor function and the use of the paretic arm and that these improvements parallel changes in the activation of the brain sensorimotor network.
Bilateral Functional Task Training which promotes the use of the paretic limb simultaneously with the nonparetic limb. Many of our daily chores are bimanual and utilize concurrent use of both arms.
Detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effects of constraint induced movement therapy post-stroke patients with motor impairment of hand in terms of grasp/grip, pinch and gross movements.
- To determine the effects of bilateral functional task training post-stroke patients with motor impairment of hand in terms of grasp/grip, pinch and gross movements.
- To determine the comparative effects of constraint, induced movement therapy versus bilateral functional task training post-stroke patients with motor impairment of hand in terms of grasp/grip, pinch and gross movements.
HYPOTHESIS:
Alternate Hypothesis:
- There will be significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of grasp/grip p\<0.05
- There will be significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of pinch and gross movements. p\<0.05
Null Hypothesis:
- There will be no significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of grasp/grip p\<0.05
- There will be no significant effect of constraint induce movement therapy versus bilateral functional task training on hand function in patients with stroke in terms of pinch and gross movements. p\<0.05
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Neuromedicine Department,Neurology OPD,Rehab OPD, Multidisciplinary Lab in FUCP, Fauji Foundation Hospital and Treatment room FUCP.
Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- Both genders.
- Age range from 40 to 60years.
- Diagnosed Cases of Stroke.
- MMT greater than Grade 2.
- Wrist ROM valid for functional tasks.
- Brunnstrom stages of recovery: Grade 4
- MAS: Grade 2 or less
Exclusion Criteria
- Active joint disease (rheumatoid, or any other rheumatological disease)
- Recent history of upper limb surgery.
- Contractures or Deformity.
- Inability to follow-2-step commands.
- Psychiatric diagnoses.
Technique: Convenience Sampling
Outcome Measures:
Data will be collected on Demographics and general information. Data will be collected using Action research arm test,Fugl-Meyer Assessment Upper Extremity (FMA-UE),Goniometry.
Experimental Group (A) = This group will receive task oriented training with bilateral functional task training and their outcomes will be measured at baseline and at the end of 10 weeks treatment..
Control group (B) =This group will undergo task oriented training with Constrained Induced Movement Therapy and their outcomes will be observed at the baseline and then after treatment of 10 weeks.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.
A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
- Task oriented training program including Constraint Induced movement therapy and Bilateral Functional Task Training for the restoration and improvement of the hand function in patients with stroke will prove effective in increasing strength and improving function along with grasp /grip pinch and gross movements.
- This study will help the practitioner to use the new treatment comparison options for treating patient's hand function improvement in stroke.
- The results of the study will add to the literature about the comparative effects of Constraint Induced movement therapy and Bilateral Functional Task Training in improving hand function in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group A | Experimental | Procedure: Task -oriented training with bilateral functional task training exercisesIt includes participants receiving task oriented combined with bilateral functional task training exercises for 10 weeks treatment. |
| Experimental group B | Experimental | Procedure: Task Oriented Training with CIMTThis group involves participants receiving task oriented training with constrained induced movement therapy exercises for a period of 10 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Both genders.
- Age range from 40 to 60 years.
- Diagnosed Cases of Stroke.
- MMT greater than Grade 2.
- Wrist ROM valid for functional tasks.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Task -oriented training with bilateral functional task training exercisesTask oriented training approach with BFTT will consists of different tasks including: Hand Movements: 1. Fold a small cloth towel with both hands with initially putting the towel flat on the table and gradually folding it into a large towel roll. 2. Put a small amount of putty on patient's table and instruct to roll it with the help of rolling pin moving it back and forth using both the hands. 3. Place a jar with a removable lid on the table and instruct the patient to remove lid from the jar completely by holding the jar with either hand and remove the lid with the alternate hand. 4. Pouring water: Pour water from jug while holding the jug in unaffected hand to cup/glass that is held in affected hand and activity can be done the other way round as well. 5. Pour water from one hard plastic cup to another while alternatively involving both the hands (we must not allow deformation of the cup) 6. Plunging action with coffee maker against water resistance:Fill the coffee maker with water. | Procedure or surgery | Experimental group A |
| Task Oriented Training with CIMT• Hand Movements: 1. Sitting at a table (Wrist Extension): Affected forearm resting on table. Place cylindrical object in palm of patient's hand. Patient asked to move the hand towards the forearm (dorsiflexion) by extending the wrist - no elbow flexion allowed. 2. Sitting at a table (Radial Deviation of Wrist): Therapist should place forearm with ulnar side on table in mid-pronation / supination position. Thumb in line with forearm and wrist in extension. Fingers around cylindrical object. Patient is asked to lift hand off table. No wrist flexion or extension. Advanced Hand Activities: 1. Have the patient reach forward to pick up the top of a pen with their affected hand, bring the affected arm back to their side and put the pen cap down in front of them. 2. Place (beans), in a teacup an arm's length away on the affected side. Place another teacup an arm's length away on the intact side. Have the patient pick up one beans with their affected hand and place the beans in the cup on the | Procedure or surgery | Experimental group B |
Primary outcome
Upper extremity performance
Time frame: 10 weeks
Action Research Arm Test (ARAT) will be used for estimation of upper-limb function. This is a summated rating scale with 4 domains: Grasp, Grip, Pinch, and Gross. Scoring is based on the performance of several tasks from each domain. Each task is rated from 0 to 3, where higher scores denote less disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
Maryam Zahid principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task -oriented training with bilateral functional task training exercises and Task Oriented Training with CIMT in people with Stroke and Hand Function, run by Foundation University Islamabad 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 12 inclusion and 0 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 3 Oct 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?
Upper extremity performance (time frame: 10 weeks). 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 3 Oct 2024.