- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05201196
Task Oriented Training in Post Stroke Patients
Effects of Task Orientated Training on Dexterous Movement of Hand in Post Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pakistan(Punjab_
-
Lahore, Pakistan(Punjab_, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Unilateral hemiplegic stroke patients referred by Neuro-physician (both ischemic and hemiplegic stroke patients).
- Patient with first time stroke (within 6month of onset).
- Age between 45-70 years of age.
- Gender both male & females.
- Ability to comprehend simple instructions (Mini-Mental State Examination with a score of >24 ).
- Score of spasticity for upper extremity (shoulder, elbow) below and equal 2 based on the Modified Ashworth Scale (MAS).
- Motor recovery of upper limb Brunnstrom stages ≥ 4.
- Not participated to other upper-limb rehabilitation programs during the participation in this study.
Exclusion Criteria:
Recurrent stroke attacks, Transient ischemic attacks(TIA).
- Previous injury, disease, or contracture of the upper extremity and no sitting balance.
- Any comorbid neurological disease or condition such as multiple sclerosis, Parkinson disease, spinal cord injury, traumatic brain lesions, brain tumor, epilepsy, or dementia,
- Had Hemineglect phenomena.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional physical therapy
Conventional physical therapy Muscle strengthening and Muscle Stretching, TENS.
|
Targeted muscle stretching and Strengthening (flexors, Extensors, abductors, internal and external rotators, of Shoulder, Elbow, forearm (supination & pronation) and hand 10 repetitions×1 set, 4 days/ week.
Transcutaneous Electrical nerve Stimulation for 10-20 min, 4 days/ week.
Total of 16 sessions were given each consisting of 45 mins.
|
|
Experimental: Task Oriented Training
Experimental group was given Task Oriented protocol including different task specific functional activities
|
Experimental group was given Task oriented protocol including activities such as Table-top polishing, Arm cradling, Reach forward and pick-up or touch an object, Reached sideway to pick-up an object and transferring it to a table in front, Pouring ½ cup of water from a measuring pot into wide mouth glass held in opposite hand, Picking up pen from thumb and first two fingers, lifting a basket and placing it on the table 10 repetitions×1 set for each activity, 4-5days/week. Total of 16 sessions were given each consisting of 45 mins |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Time Frame: Pre treatment as baseline
|
Fugl-Meyer upper extremity evaluates voluntary movement, reflex activity, grasp, and coordination.
Performance is measured on with a 3-point ordinal scale (0 to 2), with a maximum score of 30 with sub score 10 for the wrist, 14 for the hand, and for coordination and speed of movement the score is 6
|
Pre treatment as baseline
|
|
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Time Frame: Mid treatment after 3 weeks
|
Fugl-Meyer upper extremity evaluates voluntary movement, reflex activity, grasp, and coordination.
Performance is measured on with a 3-point ordinal scale (0 to 2), with a maximum score of 30 with sub score 10 for the wrist, 14 for the hand, and for coordination and speed of movement the score is 6
|
Mid treatment after 3 weeks
|
|
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Time Frame: Post treatment after 6 weeks
|
Fugl-Meyer upper extremity evaluates voluntary movement, reflex activity, grasp, and coordination.
Performance is measured on with a 3-point ordinal scale (0 to 2), with a maximum score of 30 with sub score 10 for the wrist, 14 for the hand, and for coordination and speed of movement the score is 6
|
Post treatment after 6 weeks
|
|
Wolf Motor Function Test (WMFT)
Time Frame: Pre treatment as baseline
|
Wolf motor function is a quantitative measure used for upper extremity motor ability using timed and functional tasks.
It comprises of 15 function-based tasks and 2-strength based tasks.
Maximum score is 75 and Lower scores are suggests low level of functioning.
Time required for the task vary with individuals and usually 15-20 minutes
|
Pre treatment as baseline
|
|
Wolf Motor Function Test (WMFT)
Time Frame: Mid treatment after 3 weeks
|
Wolf motor function is a quantitative measure used for upper extremity motor ability using timed and functional tasks.
It comprises of 15 function-based tasks and 2-strength based tasks.
Maximum score is 75 and Lower scores are suggests low level of functioning.
Time required for the task vary with individuals and usually 15-20 minutes
|
Mid treatment after 3 weeks
|
|
Wolf Motor Function Test (WMFT)
Time Frame: Post treatment after 6 weeks
|
Wolf motor function is a quantitative measure used for upper extremity motor ability using timed and functional tasks.
It comprises of 15 function-based tasks and 2-strength based tasks.
Maximum score is 75 and Lower scores are suggests low level of functioning.
Time required for the task vary with individuals and usually 15-20 minutes
|
Post treatment after 6 weeks
|
|
Barthel Index
Time Frame: Pre treatment as baseline
|
Barthel index include the data obtained from the patient's self-report, or from one of his attendants.
It include 10-activities of daily living.
These outcome measures are administrated at initial before 3 days of treatment, middle at 6 session and posttreatment
|
Pre treatment as baseline
|
|
Barthel Index
Time Frame: Mid treatment after 3 weeks
|
Barthel index include the data obtained from the patient's self-report, or from one of his attendants.
It include 10-activities of daily living.
These outcome measures are administrated at initial before 3 days of treatment, middle at 6 session and posttreatment
|
Mid treatment after 3 weeks
|
|
Barthel Index
Time Frame: Post treatment after 6 weeks
|
Barthel index include the data obtained from the patient's self-report, or from one of his attendants.
It include 10-activities of daily living.
These outcome measures are administrated at initial before 3 days of treatment, middle at 6 session and posttreatment
|
Post treatment after 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/21/0235 Tahreem Zaman
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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