StrokeNCT05391009
Comparison of PNF and Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
A study testing PNF and TRT in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
Comparison of PNF and Task Related Techniques Along with Tens on Upper Limb Function Among Stroke Patients Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- PNF and TRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Mar 2022to Sep 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of illness before participation in the study ranged from six to eighteen months' post stroke.
- Patients who diagnosed with ischemic stroke stage 2 and 3
- Patients' age ranged from 50-70 years (male/female)
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions (mini mental scale)
Who cannot join
- Patients with communication problems
- Patients with a history of previous stroke or other neurological diseases or disorders
- Patients with inflammation, old fracture or prosthesis in the affected limb, neurological diseases that affect upper limb function other than stroke (e.g.: Multiple sclerosis, Peripheral neuropathy, Parkinsonism .... etc.), infection or dermatological conditions on acupuncture sites, musculoskeletal disorders such as severe arthritis, cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, arrhythmia, implanted pacemaker or unstable hypertension) or pulmonary disorders, visual and auditory problems and patients with cognitive impairment.
- Any Contra indications for TENS, Other neurological \& orthopedic conditions affecting upper limb, Patient with subluxed shoulder, Patient with shoulder hand syndrome.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
General hospital, Al Shafi hospital, CH. Muhammad Akram Hospital Hameed Latif Hospital.
Lahore
About this study
Comparison of PNF and Task Related Techniques Along with Tens on Upper Limb Function Among Stroke Patients
Read the detailed description
The objective of this study is to determine the comparison of PNF and TRT along with TENs on upper limb function recovery among stroke patients.
- Conditions
- Stroke
- Being tested
- PNF, TRT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNFDiagnostic test
PNF exercise twice daily five days per week for 8 weeks. D1 and D2 flexion and extension pattern for upper limb. In D1 Flexion-adduction -external rotation d1, extension -abduction-internal rotation and in D2 flexion-abduction-external rotation, extension-adduction-internal rotation
TRTDiagnostic test
The duration of a TRT session Will be 60 min. Each session started with warm-up exercises for 10 min followed by 50 min of TRT. Each task will be repeated approximately 10 to 20 times, for 1 to 5 sets, or alternatively for 2 to 5 min. A 2 min rest period after every 15 min of practice will be allowed. Before commencing the exercise session, tasks will be demonstrated to each patient using the non-affected UE.
| Study group | Role | What they receive |
|---|---|---|
| PNF GROUP | Experimental | PNF exercise twice daily five days per week for 8 weeks. D1 and D2 flexion and extension pattern for upper limb. In D1 Flexion-adduction -external rotation d1, extension -abduction-internal rotation and in D2 flexion-abduction-external rotation, extension-adduction-internal rotation Receives: Diagnostic Test: PNF |
| TRT GROUP | Experimental | The duration of a TRT session Will be 60 min. Each session started with warm-up exercises for 10 min followed by 50 min of TRT. Each task will be repeated approximately 10 to 20 times, for 1 to 5 sets, or alternatively for 2 to 5 min. A 2 min rest period after every 15 min of practice will be allowed. Before commencing the exercise session, tasks will be demonstrated to each patient using the non-affected UE. Receives: Diagnostic Test: TRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
The duration of a TRT session Will be 60 min. Each session started with warm-up exercises for 10 min followed by 50 min of TRT. Modified ashworth scale (mas) Box and block test
Measured: 6 Months
Secondary outcomes (1)
PNF Techniques Along With Tens on Upper Limb Function Among Stroke Patients
PNF exercise twice daily five days per week for 8 weeks. D1 and D2 flexion and extension pattern for upper limb. Mini Mental Scale
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start31 Mar 2022
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
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.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391009
- Sponsor's protocol ID
- DPT/Batch-Fall17/513
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 25 May 2022
- Results posted
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PNF and Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
- ClinicalTrials.gov ID
- NCT05391009
- Acronym / sponsor ID
- DPT/Batch-Fall17/513
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 May 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.
Comparison of PNF and Task Related Techniques Along with Tens on Upper Limb Function Among Stroke Patients
Detailed description
The objective of this study is to determine the comparison of PNF and TRT along with TENs on upper limb function recovery among stroke patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF GROUP | Experimental | Diagnostic Test: PNFPNF exercise twice daily five days per week for 8 weeks. D1 and D2 flexion and extension pattern for upper limb. In D1 Flexion-adduction -external rotation d1, extension -abduction-internal rotation and in D2 flexion-abduction-external rotation, extension-adduction-internal rotation |
| TRT GROUP | Experimental | Diagnostic Test: TRTThe duration of a TRT session Will be 60 min. Each session started with warm-up exercises for 10 min followed by 50 min of TRT. Each task will be repeated approximately 10 to 20 times, for 1 to 5 sets, or alternatively for 2 to 5 min. A 2 min rest period after every 15 min of practice will be allowed. Before commencing the exercise session, tasks will be demonstrated to each patient using the non-affected UE. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Duration of illness before participation in the study ranged from six to eighteen months' post stroke.
- Patients who diagnosed with ischemic stroke stage 2 and 3
- Patients' age ranged from 50-70 years (male/female)
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions (mini mental scale)
Key exclusion criteria (4 listed)
- Patients with communication problems
- Patients with a history of previous stroke or other neurological diseases or disorders
- Patients with inflammation, old fracture or prosthesis in the affected limb, neurological diseases that affect upper limb function other than stroke (e.g.: Multiple sclerosis, Peripheral neuropathy, Parkinsonism .... etc.), infection or dermatological conditions on acupuncture sites, musculoskeletal disorders such as severe arthritis, cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, arrhythmia, implanted pacemaker or unstable hypertension) or pulmonary disorders, visual and auditory problems and patients with cognitive impairment.
- Any Contra indications for TENS, Other neurological \& orthopedic conditions affecting upper limb, Patient with subluxed shoulder, Patient with shoulder hand syndrome.
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 |
|---|---|---|
| PNFPNF exercise twice daily five days per week for 8 weeks. D1 and D2 flexion and extension pattern for upper limb. In D1 Flexion-adduction -external rotation d1, extension -abduction-internal rotation and in D2 flexion-abduction-external rotation, extension-adduction-internal rotation | Diagnostic test | PNF GROUP |
| TRTThe duration of a TRT session Will be 60 min. Each session started with warm-up exercises for 10 min followed by 50 min of TRT. Each task will be repeated approximately 10 to 20 times, for 1 to 5 sets, or alternatively for 2 to 5 min. A 2 min rest period after every 15 min of practice will be allowed. Before commencing the exercise session, tasks will be demonstrated to each patient using the non-affected UE. | Diagnostic test | TRT GROUP |
Primary outcome
Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
Time frame: 6 Months
The duration of a TRT session Will be 60 min. Each session started with warm-up exercises for 10 min followed by 50 min of TRT. Modified ashworth scale (mas) Box and block test
1 secondary outcome
PNF Techniques Along With Tens on Upper Limb Function Among Stroke Patients
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF and TRT in people with Stroke, run by Superior 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 4 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: status not confirmed, as of the sponsor's last update on 25 May 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?
Results are not available in the source record.
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?
Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients (time frame: 6 Months). 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 25 May 2022.