Task Oriented Training in Post Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional physical therapy
Task Oriented Training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Task, Training, Movement
Eligibility Criteria
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.
Sites / Locations
- Riphah international university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional physical therapy
Task Oriented Training
Arm Description
Conventional physical therapy Muscle strengthening and Muscle Stretching, TENS.
Experimental group was given Task Oriented protocol including different task specific functional activities
Outcomes
Primary Outcome Measures
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
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
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
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
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
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
Wolf Motor Function Test (WMFT)
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
Wolf Motor Function Test (WMFT)
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
Wolf Motor Function Test (WMFT)
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
Barthel Index
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
Barthel Index
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
Barthel Index
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05201196
First Posted
November 8, 2021
Last Updated
April 4, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05201196
Brief Title
Task Oriented Training in Post Stroke Patients
Official Title
Effects of Task Orientated Training on Dexterous Movement of Hand in Post Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be observe the effect of Task-oriented training on the dexterous movements of hands in hemiparetic post-stroke patients. Patient will be recruited that meet the inclusion criteria, with unilateral hemiplegia referred by Neurophysician having stroke for the first time, between age 47-70 year, both males and females, score of spasticity for upper extremity (shoulder, elbow) below and equal 2 based on the Modified Ashworth Scale (MAS), ability to comprehend simple instructions (Mini-Mental State Examination with a minimum score > 24), Brunnstrom stages ≥ 4, not submitted to other upper-limb rehabilitation programs during the participation in this study. The individuals with recurrent stroke episodes and transient ischemic attack, other neurological diseases (Parkinson's disease, multiple sclerosis,), hemineglect, no sitting balance and comorbidities are excluded. Outcome measures used are FuglMeyer assessment scale (wrist and hand) and Wolf motor function test for upper extremity while Barthel index to assess the activities of daily living. All procedures will perform by taking informed consent. All Ethical standards for both patient and institution will be followed. After collecting data, will apply Shapiro Wilk test to check the normal distribution of data. For analysis use SPSS version 25
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Task, Training, Movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Conventional physical therapy Muscle strengthening and Muscle Stretching, TENS.
Arm Title
Task Oriented Training
Arm Type
Experimental
Arm Description
Experimental group was given Task Oriented protocol including different task specific functional activities
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Task Oriented Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Description
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
Time Frame
Pre treatment as baseline
Title
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Description
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
Time Frame
Mid treatment after 3 weeks
Title
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Description
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
Time Frame
Post treatment after 6 weeks
Title
Wolf Motor Function Test (WMFT)
Description
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
Time Frame
Pre treatment as baseline
Title
Wolf Motor Function Test (WMFT)
Description
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
Time Frame
Mid treatment after 3 weeks
Title
Wolf Motor Function Test (WMFT)
Description
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
Time Frame
Post treatment after 6 weeks
Title
Barthel Index
Description
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
Time Frame
Pre treatment as baseline
Title
Barthel Index
Description
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
Time Frame
Mid treatment after 3 weeks
Title
Barthel Index
Description
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
Time Frame
Post treatment after 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tehreem Mukhtar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international university
City
Lahore
State/Province
Pakistan(Punjab_
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Task Oriented Training in Post Stroke Patients
We'll reach out to this number within 24 hrs