Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625294
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
Sponsor:
None
Organization:
None
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:
No
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 graspgrip 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 graspgrip 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 graspgrip 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 graspgrip plt005
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 plt005
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 graspgrip plt005
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 plt005
Research Design Experimental study Randomized Control Trial
Clinical setting Neuromedicine DepartmentNeurology OPDRehab 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 testFugl-Meyer Assessment Upper Extremity FMA-UEGoniometry
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 patients 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 graspgrip 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 graspgrip 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 graspgrip 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 graspgrip plt005
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 plt005
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 graspgrip plt005
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 plt005
Research Design Experimental study Randomized Control Trial
Clinical setting Neuromedicine DepartmentNeurology OPDRehab 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 testFugl-Meyer Assessment Upper Extremity FMA-UEGoniometry
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 patients 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None