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Completed

NCT Number: NCT05201196

Task Oriented Training in Post Stroke Patients

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah international university

Lahore, Pakistan(Punjab_, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional physical therapy

Other

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.

Task Oriented Training

Other

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Task Orientated Training on Dexterous Movement of Hand in Post Stroke Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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