Hemiplegic StrokeNCT05379998
Neural Mobilization Versus PNF Hold Relax Technique on Lower Extremity in Hemiplegic Stroke
A study testing Neural mobilization and PNF hold relax technique in people with Hemiplegic Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted. This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hemiplegic Stroke
- What is being tested?
- Neural mobilization and PNF hold relax technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2022to 20 Nov 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with subacute to chronic (3-12months) Hemiplegic Stroke.
- Both Genders.
- Age between 20 and 70 years.
- Patients classified as grade 2 and 3 as per the Modified Rankin scale.
- Patients with or without assistive devices.
Who cannot join
- Patients having cardiac disorders, rheumatic and orthopedic diseases that would impede the performance of the technique.
- Patients who have undergone some surgery recently.
- Patients having cognitive impairments.
- Contractures of the lower limb joints.
- Patients having associated Neurological Pathologies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Neural Mobilization and Proprioceptive Neuromuscular Facilitation Hold Relax Technique on Lower Limb Motor Function in Hemiplegic Stroke
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted. This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques.
Read the detailed description
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted. Evidence regarding the comparison of these two techniques is sparse and is based on different clinical experiences and a less number of studies with limited methodological design. There has been no work regarding the long term effects of these two techniques in improving lower limb motor function in Hemiplegic stroke patients. This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques. A total of 54 patients diagnosed with Hemiplegic stroke will be selected for the collection of data according to the inclusion criteria. Patients will be divided into two groups, Group A and Group B. Group A will receive sciatic nerve mobilization (sliding technique) and Group B will receive Proprioceptive neuromuscular mobilization Hold relax technique 3 days a week for 30 mins per day for 6 weeks. Sciatic nerve mobilizations (sliding technique) will be performed for a duration of 1 minute each for 6 such sets with 60 seconds rest period followed by every set. The Hold Relax Technique of Hamstring will be performed with each hold period lasting for 10 seconds followed by a relaxation phase of 10-15 seconds for 10 repetitions. Data will be collected at baseline, after 3weeks and at 6 weeks after intervention from both groups. Gait will be measured using TUG (Timed up and go), Quality of life will be measured using the Urdu version of SS-QOL(stroke-specific quality of life)and lower limb motor function will be measured using fugl Meyer scale(lower extremity)
- Conditions
- Hemiplegic Stroke
- Being tested
- Neural mobilization, PNF hold relax technique
- Keywords
- Neural mobilization, PNF hold relax, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilizationOther
Sciatic nerve mobilization (sliding technique) will be performed by a physical therapist. The sciatic nerve mobilization technique improves the nerve mobility of the hemiparetic lower limb in a nervous system patient and is helpful in increasing the ROM of the lower limbs without resistance.
PNF hold relax techniqueOther
Proprioceptive neuromuscular facilitation hold relaxation technique of hamstring muscle will be performed by the physical therapist three days a week for 6 weeks. In the hold relax technique after reaching the point of resistance, an isometric contraction is performed against the resistance to get a pain free response.
| Study group | Role | What they receive |
|---|---|---|
| Group A(neural mobilization) | Experimental | sciatic nerve mobilization(sliding technique) Receives: Other: Neural mobilization |
| Group B(PNF hold relax) | Experimental | PNF hold relax technique of Hamstring muscle Receives: Other: PNF hold relax technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl meyer(lower extremity)
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients. The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed. Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
Measured: baseline
Fugl meyer(lower extremity)
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients. The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed. Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
Measured: 3 weeks
Fugl meyer(lower extremity)
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients. The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed. Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
Measured: 6 weeks
Timed up and go (TUG)
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults. This test is simple and used to measure the risk of falls, and the progress of walking, balance and sit to stand. The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec shows complete independence for ambulation and transfers (with and without walking aid). An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
Measured: baseline
Timed up and go (TUG)
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults. This test is simple and used to measure the risk of falls, and the progress of walking, balance and sitting to stand. The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec shows complete independence for ambulation and transfers (with and without walking aid). An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
Measured: 3 weeks
Timed up and go (TUG)
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults. This test is simple and used to measure the risk of falls, and the progress of walking, balance and sitting to stand. The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec shows complete independence for ambulation and transfers (with and without walking aid). An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
Measured: 6 weeks
Stroke specific quality of life (SS-QOL)
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients. Urdu version of the stroke-specific quality of life scale will be used. The total score ranges from 49 to 245 with higher scores indicating higher quality of life. The minimum score is 49.
Measured: baseline
Stroke specific quality of life (SS-QOL)
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients. Urdu version of the stroke-specific quality of life scale will be used. The total score ranges from 49 to 245 with higher scores indicating higher quality of life. The minimum score is 49.
Measured: 3 weeks
Stroke specific quality of life (SS-QOL)
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients. Urdu version of the stroke-specific quality of life scale will be used. The total score ranges from 49 to 245 with higher scores indicating higher quality of life. The minimum score is 49.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 May 2022
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379998
- Sponsor's protocol ID
- REC/01244 Nida khan
- Status last verified
- Nov 2022
- First submitted
- 13 May 2022
- Last updated
- 28 Nov 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Neural Mobilization and Proprioceptive Neuromuscular Facilitation Hold Relax Technique on Lower Limb Motor Function in Hemiplegic Stroke
- ClinicalTrials.gov ID
- NCT05379998
- Acronym / sponsor ID
- REC/01244 Nida khan
- Conditions
- Hemiplegic Stroke
- Keywords
- Neural mobilization, PNF hold relax, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 18 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.
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted. This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques.
Detailed description
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted. Evidence regarding the comparison of these two techniques is sparse and is based on different clinical experiences and a less number of studies with limited methodological design. There has been no work regarding the long term effects of these two techniques in improving lower limb motor function in Hemiplegic stroke patients. This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques. A total of 54 patients diagnosed with Hemiplegic stroke will be selected for the collection of data according to the inclusion criteria. Patients will be divided into two groups, Group A and Group B. Group A will receive sciatic nerve mobilization (sliding technique) and Group B will receive Proprioceptive neuromuscular mobilization Hold relax technique 3 days a week for 30 mins per day for 6 weeks. Sciatic nerve mobilizations (sliding technique) will be performed for a duration of 1 minute each for 6 such sets with 60 seconds rest period followed by every set. The Hold Relax Technique of Hamstring will be performed with each hold period lasting for 10 seconds followed by a relaxation phase of 10-15 seconds for 10 repetitions. Data will be collected at baseline, after 3weeks and at 6 weeks after intervention from both groups. Gait will be measured using TUG (Timed up and go), Quality of life will be measured using the Urdu version of SS-QOL(stroke-specific quality of life)and lower limb motor function will be measured using fugl Meyer scale(lower extremity)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A(neural mobilization) | Experimental | Other: Neural mobilizationsciatic nerve mobilization(sliding technique) |
| Group B(PNF hold relax) | Experimental | Other: PNF hold relax techniquePNF hold relax technique of Hamstring muscle |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with subacute to chronic (3-12months) Hemiplegic Stroke.
- Both Genders.
- Age between 20 and 70 years.
- Patients classified as grade 2 and 3 as per the Modified Rankin scale.
- Patients with or without assistive devices.
Key exclusion criteria (5 listed)
- Patients having cardiac disorders, rheumatic and orthopedic diseases that would impede the performance of the technique.
- Patients who have undergone some surgery recently.
- Patients having cognitive impairments.
- Contractures of the lower limb joints.
- Patients having associated Neurological Pathologies.
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 |
|---|---|---|
| Neural mobilizationSciatic nerve mobilization (sliding technique) will be performed by a physical therapist. The sciatic nerve mobilization technique improves the nerve mobility of the hemiparetic lower limb in a nervous system patient and is helpful in increasing the ROM of the lower limbs without resistance. | Other | Group A(neural mobilization) |
| PNF hold relax techniqueProprioceptive neuromuscular facilitation hold relaxation technique of hamstring muscle will be performed by the physical therapist three days a week for 6 weeks. In the hold relax technique after reaching the point of resistance, an isometric contraction is performed against the resistance to get a pain free response. | Other | Group B(PNF hold relax) |
Primary outcome
Fugl meyer(lower extremity)
Time frame: baseline
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients. The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed. Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
Fugl meyer(lower extremity)
Time frame: 3 weeks
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients. The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed. Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
Fugl meyer(lower extremity)
Time frame: 6 weeks
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients. The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed. Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
Timed up and go (TUG)
Time frame: baseline
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults. This test is simple and used to measure the risk of falls, and the progress of walking, balance and sit to stand. The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec shows complete independence for ambulation and transfers (with and without walking aid). An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
Timed up and go (TUG)
Time frame: 3 weeks
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults. This test is simple and used to measure the risk of falls, and the progress of walking, balance and sitting to stand. The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec shows complete independence for ambulation and transfers (with and without walking aid). An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
Timed up and go (TUG)
Time frame: 6 weeks
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults. This test is simple and used to measure the risk of falls, and the progress of walking, balance and sitting to stand. The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec shows complete independence for ambulation and transfers (with and without walking aid). An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
Stroke specific quality of life (SS-QOL)
Time frame: baseline
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients. Urdu version of the stroke-specific quality of life scale will be used. The total score ranges from 49 to 245 with higher scores indicating higher quality of life. The minimum score is 49.
Stroke specific quality of life (SS-QOL)
Time frame: 3 weeks
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients. Urdu version of the stroke-specific quality of life scale will be used. The total score ranges from 49 to 245 with higher scores indicating higher quality of life. The minimum score is 49.
Stroke specific quality of life (SS-QOL)
Time frame: 6 weeks
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients. Urdu version of the stroke-specific quality of life scale will be used. The total score ranges from 49 to 245 with higher scores indicating higher quality of life. The minimum score is 49.
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 28 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Hemiplegic Stroke
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Not yet recruiting
Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
Hemiplegic Shoulder Pain
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Stroke, Acute, Gait, Hemiplegic
Recruiting
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Stroke
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.
Imran Amjad, PhD 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 Neural mobilization and PNF hold relax technique in people with Hemiplegic 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 5 inclusion and 5 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 28 Nov 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(lower extremity) (time frame: 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 28 Nov 2022.