Clinical trial NCT06625294: Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
Official title: Comparative Effects of Constraint-Induced Movement Therapy With Bilateral Functional Task Training On Hand Function In Patients With Stroke
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Hand Function
Keywords: Task Oriented Training
Constraint-Induced Movement Therapy
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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\&lt;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\&lt;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\&lt;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\&lt;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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Upper extremity performance
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
affiliation: Foundation University Islamabad
name: Maryam Zahid
role: PRINCIPAL_INVESTIGATOR
References: