Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT06625294
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-03
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
Sponsor:
Foundation University Islamabad
Organization:
Study Overview
Official Title:
Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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:
1. 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.
2. 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.
3. 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:
1. 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
2. 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:
1. 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
2. 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
1. Both genders.
2. Age range from 40 to 60years.
3. Diagnosed Cases of Stroke.
4. MMT greater than Grade 2.
5. Wrist ROM valid for functional tasks.
6. Brunnstrom stages of recovery: Grade 4
7. MAS: Grade 2 or less
Exclusion Criteria
1. Active joint disease (rheumatoid, or any other rheumatological disease)
2. Recent history of upper limb surgery.
3. Contractures or Deformity.
4. Inability to follow-2-step commands.
5. 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:
1. 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.
2. This study will help the practitioner to use the new treatment comparison options for treating patient's hand function improvement in stroke.
3. 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.
The objectives of this study are:
1. 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.
2. 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.
3. 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:
1. 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
2. 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:
1. 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
2. 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
1. Both genders.
2. Age range from 40 to 60years.
3. Diagnosed Cases of Stroke.
4. MMT greater than Grade 2.
5. Wrist ROM valid for functional tasks.
6. Brunnstrom stages of recovery: Grade 4
7. MAS: Grade 2 or less
Exclusion Criteria
1. Active joint disease (rheumatoid, or any other rheumatological disease)
2. Recent history of upper limb surgery.
3. Contractures or Deformity.
4. Inability to follow-2-step commands.
5. 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:
1. 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.
2. This study will help the practitioner to use the new treatment comparison options for treating patient's hand function improvement in stroke.
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: