NCT05201196

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

November 8, 2021

Last Update Submit

April 4, 2022

Conditions

Keywords

StrokeTaskTrainingMovement

Outcome Measures

Primary Outcomes (9)

  • 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

    Pre treatment as baseline

  • 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

    Mid treatment after 3 weeks

  • 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

    Post treatment after 6 weeks

  • 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

    Pre treatment as baseline

  • 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

    Mid treatment after 3 weeks

  • 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

    Post treatment after 6 weeks

  • 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

    Pre treatment as baseline

  • 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

    Mid treatment after 3 weeks

  • 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

    Post treatment after 6 weeks

Study Arms (2)

Conventional physical therapy

ACTIVE COMPARATOR

Conventional physical therapy Muscle strengthening and Muscle Stretching, TENS.

Other: Conventional physical therapy

Task Oriented Training

EXPERIMENTAL

Experimental group was given Task Oriented protocol including different task specific functional activities

Other: Task Oriented Training

Interventions

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.

Conventional physical therapy

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

Task Oriented Training

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Pakistan(Punjab_, 54000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tehreem Mukhtar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

January 21, 2022

Study Start

August 15, 2021

Primary Completion

January 15, 2022

Study Completion

January 30, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations