StrokeNCT05201196
Task Oriented Training in Post Stroke Patients
A study testing Conventional physical therapy and Task Oriented Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional physical therapy and Task Oriented Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Pakistan(Punjab_, 54000
About this study
Official title: Effects of Task Orientated Training on Dexterous Movement of Hand 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
- Conditions
- Stroke
- Being tested
- Conventional physical therapy, Task Oriented Training
- Keywords
- Stroke, Task, Training, Movement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
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 TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy | Active comparator | Conventional physical therapy Muscle strengthening and Muscle Stretching, TENS. Receives: Other: Conventional physical therapy |
| Task Oriented Training | Experimental | Experimental group was given Task Oriented protocol including different task specific functional activities Receives: Other: Task Oriented Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post treatment after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Aug 2021
- Primary completion15 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201196
- Sponsor's protocol ID
- REC/Lhr/21/0235 Tahreem Zaman
- Status last verified
- Apr 2022
- First submitted
- 8 Nov 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task Orientated Training on Dexterous Movement of Hand in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT05201196
- Acronym / sponsor ID
- REC/Lhr/21/0235 Tahreem Zaman
- Conditions
- Stroke
- Keywords
- Stroke, Task, Training, Movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy | Active comparator | Other: Conventional physical therapyConventional physical therapy Muscle strengthening and Muscle Stretching, TENS. |
| Task Oriented Training | Experimental | Other: Task Oriented TrainingExperimental group was given Task Oriented protocol including different task specific functional activities |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physical therapyTargeted 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. | Other | Conventional physical therapy |
| Task Oriented TrainingExperimental 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 | Other | Task Oriented Training |
Primary outcome
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehreem Mukhtar, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy and Task Oriented Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Assessment (FMA-UE) (time frame: Pre treatment as baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.