ElderlyNCT06747741
Effects of PNF Stretching vs Conventional Physical Therapy on the Symptoms of Restless Leg Syndrome in Elderly Population.
A study testing PNF stretching(Contract relax with agonist contraction) and Conventional physical therapy in people with Elderly and Restless Leg Syndrome (RLS), run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Restless leg Syndrome (RLS) is a common condition in the elderly population,characterized byan uncontrollable urge to move the leg,often occuring in the evening or at night,which can significantly disturb sleep and daily activities(ADL). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Restless Leg Syndrome (RLS), Proprioceptive Neuromuscular Facilitation
- What is being tested?
- PNF stretching(Contract relax with agonist contraction) and Conventional physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 20 Dec 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 and above.
- Male \& Females both.
- must fulfill the diagnostic criteria of primary RLS.
Who cannot join
- A history or underlying disease that would contribute to the symptoms of RLS.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Thrapy
Islamabad, 44000
Sana Khalid, MS-NMPT, +923444218174, sana.khalid@fui.edu.pk
About this study
Restless leg Syndrome (RLS) is a common condition in the elderly population,characterized byan uncontrollable urge to move the leg,often occuring in the evening or at night,which can significantly disturb sleep and daily activities(ADL).
Although various type of stretchings found to be effective on the symptoms of RLS,no study has specifically compared the effects of Proprioceptive Neuromuscular Facilitation stretching technique versus conventional physical therapy on the symptoms of RLS and related sleep disturbances.This study aims to fill this gap by evaluating the effectiveness of PNF stretching compared to conventional physical therapy,on the symptoms of RLS in elderly population.
Read the detailed description
OBJECTIVES:
Objectives of this study are:
- To determine the effect of PNF stretching VS conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
- To determine the effect of PNF stretching VS conventional physical therapy on sleep disturbance related to restless leg syndrome in elder population.
HYPOTHESIS:
Alternate Hypothesis:
- There is statistically significant difference between the effect of PNF stretching VS Conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
- There is statistically significant difference between the effect of PNF stretching VS conventional physical therapy on the sleep disturbance related to restless leg syndrome in elder population.
Null Hypothesis:
- There is no statistically significant difference between the effect of PNF stretching VS conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
- There is no statistically significant difference between the effect of PNF stretching VS conventional physical therapy on sleep disturbance related to restless leg syndrome in elder population.
Study Design: Randomized Controlled Trial
Clinical setting: Fauji foundation Hospital(Rehab Depart) Islamabad Healing Center. Study Duration: 1year
SELECTION CRITERIA:
Inclusion Criteria:
- Age 60 and above.
- Both male and female.
- Must fulfil the diagnostic criteria of primary restless leg syndrome.
Exclusion Criteria:
1.A history or underlying disease that would contribute to the syptoms of RLS.
Sampling Technique:Non probability purposive samping.
Data will be collected on demographics and general information. Data will be coollected using International Restless leg syndrome rating scale,Post-sleep questionnaire.
Experimental Group:This group will receive PNF stretching technique of Hold-relax with agonist contraction,outcome will measure before and after the treatment of 4 weeks.
Control Group:This group will receive conventional physical therapy,Outcome will measure before and after 4 weeks of treatment.
Data will be analyze through SPSS21 and data will be analyzed based on study design choosen that is Randomize control study with in the community.
The printed questionnaire will be provided to the patients after obtaining written consent and providing adequate information regarding the study,after which the data will be presented in the form of graphs or tables.
Significance of the study:
Although PNF stretching proves to be more effective in reducing pain increasing ROM and flexibility,but there is limited documentation about its effect on RLS.
This study aims to uncover and augument the treatment strategies that can wield even more favourable results in elder population dealing with Restless leg syndrome and also sleep disturbance related to it.
So it will aid therapist in choosing right technique saving their time and patient's investment.
- Conditions
- Elderly, Restless Leg Syndrome (RLS), Proprioceptive Neuromuscular Facilitation, Sleep Disturbance
- Being tested
- PNF stretching(Contract relax with agonist contraction), Conventional physical therapy
- Keywords
- Elderly, Restless Leg Syndrome, Sleep Disturbance, PNF stretching, Proprioceptive neuromuscular facilitation
- Medical subject headings
- Restless Legs Syndrome, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF stretching(Contract relax with agonist contraction)Procedure or surgery
1.Passively dorsiflex the patient's foot then ask to perform active planterflexion against resistance and hold for 7-10 sec then ask patient to perform dorsiflexion to the maximum available range.
Conventional physical therapyProcedure or surgery
Static Stretching:(Seated Calf Stretch With a Resistance Band)
- Sit on the floor with your legs extended.
- Loop a resistance band around one foot, holding both sides of it with your hands.
- Gently pull your toes toward your shin until you feel the stretch in your calf.Repeat on the other side.
Isometric Calf Raise:
- Stand with feet shoulder-width apart and arms at sides.
- Engage your abs for stability and roll up onto the balls of your feet, lifting both heels off the floor.
- Hold for 5 seconds, then return to the starting position. Frequency : 5 reps with 5-7Sec hold,3 days per week for 4 weeks (alternatively)
| Study group | Role | What they receive |
|---|---|---|
| PNF Stretching technique Group | Experimental | The participants will receive PNF stretching technique of contract-Relax with agonist contraction for 3 days per week on alternate days for the symptoms of RLS in elderly population. Receives: Procedure: PNF stretching(Contract relax with agonist contraction) |
| Conventional physical therapy Group | Active comparator | The participants will receive Conventional physical therapy including calf stretchinf and strenthening exercises, 3 days per week on alternative days for the symptoms of RLS in elder population. Receives: Procedure: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of restless leg syndrome symptoms
International Restless leg syndrome rating scale is 10 item Questionnaire,each question has 0(None) to 4(very severe) grading.Total score is 40,Mild(1-10),Moderate(11-20),Severe(21-30),Very severe(31-40).Participant will be assessed through this scoring system for the severity of RLS symptoms.
Measured: 4 weeks
Sleep disturbance related to RLS
5 Item questionnaire related to quality of sleep.Higher score indicate higher sleep disturbance.quality of sleep of participant will be assess through this questionnaire.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start20 Jun 2024
- Primary completion15 Nov 2024
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747741
- Sponsor's protocol ID
- FUI/CTR/2024/44
- Status last verified
- Oct 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PNF Stretching vs Conventional Physical Therapy on the Symptoms of Restless Leg Syndrome in Elderly Population.
- ClinicalTrials.gov ID
- NCT06747741
- Acronym / sponsor ID
- FUI/CTR/2024/44
- Conditions
- Elderly, Restless Leg Syndrome (RLS), Proprioceptive Neuromuscular Facilitation, Sleep Disturbance
- Keywords
- Elderly, Restless Leg Syndrome, Sleep Disturbance, PNF stretching, Proprioceptive neuromuscular facilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 24 Dec 2024 (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.
Restless leg Syndrome (RLS) is a common condition in the elderly population,characterized byan uncontrollable urge to move the leg,often occuring in the evening or at night,which can significantly disturb sleep and daily activities(ADL).
Although various type of stretchings found to be effective on the symptoms of RLS,no study has specifically compared the effects of Proprioceptive Neuromuscular Facilitation stretching technique versus conventional physical therapy on the symptoms of RLS and related sleep disturbances.This study aims to fill this gap by evaluating the effectiveness of PNF stretching compared to conventional physical therapy,on the symptoms of RLS in elderly population.
Detailed description
OBJECTIVES:
Objectives of this study are:
- To determine the effect of PNF stretching VS conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
- To determine the effect of PNF stretching VS conventional physical therapy on sleep disturbance related to restless leg syndrome in elder population.
HYPOTHESIS:
Alternate Hypothesis:
- There is statistically significant difference between the effect of PNF stretching VS Conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
- There is statistically significant difference between the effect of PNF stretching VS conventional physical therapy on the sleep disturbance related to restless leg syndrome in elder population.
Null Hypothesis:
- There is no statistically significant difference between the effect of PNF stretching VS conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
- There is no statistically significant difference between the effect of PNF stretching VS conventional physical therapy on sleep disturbance related to restless leg syndrome in elder population.
Study Design: Randomized Controlled Trial
Clinical setting: Fauji foundation Hospital(Rehab Depart) Islamabad Healing Center. Study Duration: 1year
SELECTION CRITERIA:
Inclusion Criteria:
- Age 60 and above.
- Both male and female.
- Must fulfil the diagnostic criteria of primary restless leg syndrome.
Exclusion Criteria:
1.A history or underlying disease that would contribute to the syptoms of RLS.
Sampling Technique:Non probability purposive samping.
Data will be collected on demographics and general information. Data will be coollected using International Restless leg syndrome rating scale,Post-sleep questionnaire.
Experimental Group:This group will receive PNF stretching technique of Hold-relax with agonist contraction,outcome will measure before and after the treatment of 4 weeks.
Control Group:This group will receive conventional physical therapy,Outcome will measure before and after 4 weeks of treatment.
Data will be analyze through SPSS21 and data will be analyzed based on study design choosen that is Randomize control study with in the community.
The printed questionnaire will be provided to the patients after obtaining written consent and providing adequate information regarding the study,after which the data will be presented in the form of graphs or tables.
Significance of the study:
Although PNF stretching proves to be more effective in reducing pain increasing ROM and flexibility,but there is limited documentation about its effect on RLS.
This study aims to uncover and augument the treatment strategies that can wield even more favourable results in elder population dealing with Restless leg syndrome and also sleep disturbance related to it.
So it will aid therapist in choosing right technique saving their time and patient's investment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF Stretching technique Group | Experimental | Procedure: PNF stretching(Contract relax with agonist contraction)The participants will receive PNF stretching technique of contract-Relax with agonist contraction for 3 days per week on alternate days for the symptoms of RLS in elderly population. |
| Conventional physical therapy Group | Active comparator | Procedure: Conventional physical therapyThe participants will receive Conventional physical therapy including calf stretchinf and strenthening exercises, 3 days per week on alternative days for the symptoms of RLS in elder population. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 and above.
- Male \& Females both.
- must fulfill the diagnostic criteria of primary RLS.
Key exclusion criteria (1 listed)
- A history or underlying disease that would contribute to the symptoms of RLS.
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 |
|---|---|---|
| PNF stretching(Contract relax with agonist contraction)1.Passively dorsiflex the patient's foot then ask to perform active planterflexion against resistance and hold for 7-10 sec then ask patient to perform dorsiflexion to the maximum available range. | Procedure or surgery | PNF Stretching technique Group |
| Conventional physical therapyStatic Stretching:(Seated Calf Stretch With a Resistance Band) 1. Sit on the floor with your legs extended. 2. Loop a resistance band around one foot, holding both sides of it with your hands. 3. Gently pull your toes toward your shin until you feel the stretch in your calf.Repeat on the other side. Isometric Calf Raise: 1. Stand with feet shoulder-width apart and arms at sides. 2. Engage your abs for stability and roll up onto the balls of your feet, lifting both heels off the floor. 3. Hold for 5 seconds, then return to the starting position. Frequency : 5 reps with 5-7Sec hold,3 days per week for 4 weeks (alternatively) | Procedure or surgery | Conventional physical therapy Group |
Primary outcome
Severity of restless leg syndrome symptoms
Time frame: 4 weeks
International Restless leg syndrome rating scale is 10 item Questionnaire,each question has 0(None) to 4(very severe) grading.Total score is 40,Mild(1-10),Moderate(11-20),Severe(21-30),Very severe(31-40).Participant will be assessed through this scoring system for the severity of RLS symptoms.
Sleep disturbance related to RLS
Time frame: 4 weeks
5 Item questionnaire related to quality of sleep.Higher score indicate higher sleep disturbance.quality of sleep of participant will be assess through this questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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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.
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 stretching(Contract relax with agonist contraction) and Conventional physical therapy in people with Elderly and Restless Leg Syndrome (RLS), run by Foundation University Islamabad 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 3 inclusion and 1 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 24 Dec 2024. 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?
Contact Syeda Kainat Zehra, DPT (+923045141136, syedazara434@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of restless leg syndrome symptoms (time frame: 4 weeks). The study lists 2 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 24 Dec 2024.