Parkinson Disease (PD)NCT06789133
Effects of Gait Training With and Without PNF on Balance ,Gait and Activities of Daily Living in Parkinson's Patients
A study testing PNF exercises and Body weight supported treadmill gait training and Body weight supported treadmill gait training and Routine physical therapy in people with Parkinson Disease (PD) and Proprioceptive Neuromuscular Facilitation, run by Riphah International University at 1 site in Pakistan.
Trial summary
Proprioceptive Neuromuscular Facilitation (PNF) and gait training exercises are specifically used to treat balance, gait and functional activities in Parkinson s patients. PNF has been compared with gait training and balance training in other conditions like stroke and multiple sclerosis but limited literatures are… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Parkinson Disease (PD), Proprioceptive Neuromuscular Facilitation
- What is being tested?
- PNF exercises and Body weight supported treadmill gait training and Body weight supported treadmill gait training and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 1 Nov 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's patients.
- Patients from both gender around the age of 45-65.
- Patient with a score of 42 above on the Berg Balance Scale.
- Patients with shuffling gait
- Patient with good cognitive function minimum score of 20 or more on Mini-mental Status Examination MMSE scale
Who cannot join
- Patients with a history of CVA.
- Patient with peripheral vascular disease.
- Patient with fracture or dislocation of lower limb.
- Patient with peripheral nerve injury
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Arthritis and spine care , Lahore General hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Gait Training With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Activities of Daily Living in Parkinson's Patients
Proprioceptive Neuromuscular Facilitation (PNF) and gait training exercises are specifically used to treat balance, gait and functional activities in Parkinson s patients. PNF has been compared with gait training and balance training in other conditions like stroke and multiple sclerosis but limited literatures are present in which PNF has been compared with gait training in Parkinson patients.
- Being tested
- PNF exercises and Body weight supported treadmill gait training, Body weight supported treadmill gait training and Routine physical therapy
- Keywords
- PNF, PD, BWSTT, ADLs
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF exercises and Body weight supported treadmill gait trainingOther
PNF Exercises:
.Proprioceptive neuromuscular facilitation exercises include D1 Flexion and D1 Extension of lower limb ,D2 flexion D2 extension of lower limb .rhythmic initiation ,hold relax ,pelvic pattern and contract relax technique . subjects will perform each exercise for 30sec with resting interval of 30 to 60 seconds Will be provided after completion of each exercise. 3 sessions will be held per week, For 8 weeks
Gait training:
Body weight supported treadmill gait training for 20 minutes 3 sessions per week.
In total all PNF exercises with gait training will be held for 40-45 minutes.
Body weight supported treadmill gait training and Routine physical therapyOther
Body Weight Supported Treadmill Training (BWSTT):
This will include body weight supported treadmill gait training. 10 % BWSTT or 20% BWSTT. The session will of 20 minutes .3 sessions will be Held per week.
Routine physical therapy:
Stretching and strengthening of lower extremities In total all BWSTT along with routine physical therapy protocol will be held for 40-45minutes .3 sessions will be held per week.
| Study group | Role | What they receive |
|---|---|---|
| PNF exercises and Body weight supported treadmill gait training | Experimental | PNF exercises and Body weight supported treadmill gait training Receives: Other: PNF exercises and Body weight supported treadmill gait training |
| Gait training without PNF | Active comparator | Treadmil gait training and Routine physical therapy Receives: Other: Body weight supported treadmill gait training and Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
The Berg Balance Scale (BBS) is a test that measures a person's balance abilities by asking them to perform 14 simple tasks, such as standing, sitting, reaching, and turning. The test is scored on a scale from 0 to 56, with higher scores indicating better balance. The BBS is used to assess people who have balance impairments due to various conditions, such as stroke, Parkinson's disease, osteoarthritis, or inner ear problems. The BBS has been shown to have good reliability and validity for measuring balance in Ho The reliability and validity of this test is 0.95 or 95%
Measured: 4 weeks
Time up and go Test
from baseline :The Time Up and Go (TUG) test is a simple and quick test that measures a person's functional mobility and fall risk. The test involves standing up from a chair, walking 10 feet, turning around, walking back, and sitting down again, while timing how long it takes to complete the task. The TUG test is used to evaluate people who have balance impairments due to various conditions, such as aging, stroke, Parkinson's disease, or vestibular disorders. The TUG test also has some limitations. The reliability of this test is 0.97 to o.99.
Measured: 4 weeks
Modified Barthel index
The Barthel Index is a scale used to measure an individual's ability to perform activities of daily living. The Reliability of MBI is 0.73 to 0.77. It is often employed in healthcare settings to evaluate functional independence, guide rehabilitation plans, and monitor progress in patients. there are 10 items, each scored from 0 to 2 or 3 points, The total score ranges from 0 to 20 or 25, with higher scores indicating greater independence. The 10 items are:
Bowel control Bladder control Grooming Toilet using Feeding Transfer (bed to chair and back) Mobility Dressing Stairs Bathing
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 posted23 Jan 2025
- Study start1 Feb 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, MSDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789133
- Sponsor's protocol ID
- REC/RCR&AHS/24/0215KainatAhmad
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazhar T, Jameel A, Sharif F, Asghar M. Effects of conventional physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait, and function in patients with Parkinson's disease. J Pak Med Assoc. 2023 Jun;73(6):1280-1283. doi: 10.47391/JPMA.6710.
PubMed 37427630Giardini M, Nardone A, Godi M, Guglielmetti S, Arcolin I, Pisano F, Schieppati M. Instrumental or Physical-Exercise Rehabilitation of Balance Improves Both Balance and Gait in Parkinson's Disease. Neural Plast. 2018 Mar 7;2018:5614242. doi: 10.1155/2018/5614242. eCollection 2018.
PubMed 29706993Alexandre de Assis IS, Luvizutto GJ, Bruno ACM, Sande de Souza LAP. The Proprioceptive Neuromuscular Facilitation Concept in Parkinson Disease: A Systematic Review and Meta-Analysis. J Chiropr Med. 2020 Sep;19(3):181-187. doi: 10.1016/j.jcm.2020.07.003. Epub 2020 Dec 15.
PubMed 33362441Mak MKY, Wong-Yu ISK. Exercise for Parkinson's disease. Int Rev Neurobiol. 2019;147:1-44. doi: 10.1016/bs.irn.2019.06.001. Epub 2019 Jun 27.
PubMed 31607351Pelicioni PHS, Menant JC, Latt MD, Lord SR. Falls in Parkinson's Disease Subtypes: Risk Factors, Locations and Circumstances. Int J Environ Res Public Health. 2019 Jun 23;16(12):2216. doi: 10.3390/ijerph16122216.
PubMed 31234571Mirelman A, Bonato P, Camicioli R, Ellis TD, Giladi N, Hamilton JL, Hass CJ, Hausdorff JM, Pelosin E, Almeida QJ. Gait impairments in Parkinson's disease. Lancet Neurol. 2019 Jul;18(7):697-708. doi: 10.1016/S1474-4422(19)30044-4. Epub 2019 Apr 8.
PubMed 30975519Nonnekes J, Nieuwboer A. Towards Personalized Rehabilitation for Gait Impairments in Parkinson's Disease. J Parkinsons Dis. 2018;8(s1):S101-S106. doi: 10.3233/JPD-181464.
PubMed 30584154
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gait Training With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Activities of Daily Living in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT06789133
- Acronym / sponsor ID
- REC/RCR&AHS/24/0215KainatAhmad
- Keywords
- PNF, PD, BWSTT, ADLs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 23 Jan 2025 (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.
Proprioceptive Neuromuscular Facilitation (PNF) and gait training exercises are specifically used to treat balance, gait and functional activities in Parkinson s patients. PNF has been compared with gait training and balance training in other conditions like stroke and multiple sclerosis but limited literatures are present in which PNF has been compared with gait training in Parkinson patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF exercises and Body weight supported treadmill gait training | Experimental | Other: PNF exercises and Body weight supported treadmill gait trainingPNF exercises and Body weight supported treadmill gait training |
| Gait training without PNF | Active comparator | Other: Body weight supported treadmill gait training and Routine physical therapyTreadmil gait training and Routine physical therapy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's patients.
- Patients from both gender around the age of 45-65.
- Patient with a score of 42 above on the Berg Balance Scale.
- Patients with shuffling gait
- Patient with good cognitive function minimum score of 20 or more on Mini-mental Status Examination MMSE scale
Key exclusion criteria (4 listed)
- Patients with a history of CVA.
- Patient with peripheral vascular disease.
- Patient with fracture or dislocation of lower limb.
- Patient with peripheral nerve injury
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 exercises and Body weight supported treadmill gait trainingPNF Exercises: .Proprioceptive neuromuscular facilitation exercises include D1 Flexion and D1 Extension of lower limb ,D2 flexion D2 extension of lower limb .rhythmic initiation ,hold relax ,pelvic pattern and contract relax technique . subjects will perform each exercise for 30sec with resting interval of 30 to 60 seconds Will be provided after completion of each exercise. 3 sessions will be held per week, For 8 weeks Gait training: Body weight supported treadmill gait training for 20 minutes 3 sessions per week. In total all PNF exercises with gait training will be held for 40-45 minutes. | Other | PNF exercises and Body weight supported treadmill gait training |
| Body weight supported treadmill gait training and Routine physical therapyBody Weight Supported Treadmill Training (BWSTT): This will include body weight supported treadmill gait training. 10 % BWSTT or 20% BWSTT. The session will of 20 minutes .3 sessions will be Held per week. Routine physical therapy: Stretching and strengthening of lower extremities In total all BWSTT along with routine physical therapy protocol will be held for 40-45minutes .3 sessions will be held per week. | Other | Gait training without PNF |
Primary outcome
Berg balance scale
Time frame: 4 weeks
The Berg Balance Scale (BBS) is a test that measures a person's balance abilities by asking them to perform 14 simple tasks, such as standing, sitting, reaching, and turning. The test is scored on a scale from 0 to 56, with higher scores indicating better balance. The BBS is used to assess people who have balance impairments due to various conditions, such as stroke, Parkinson's disease, osteoarthritis, or inner ear problems. The BBS has been shown to have good reliability and validity for measuring balance in Ho The reliability and validity of this test is 0.95 or 95%
Time up and go Test
Time frame: 4 weeks
from baseline :The Time Up and Go (TUG) test is a simple and quick test that measures a person's functional mobility and fall risk. The test involves standing up from a chair, walking 10 feet, turning around, walking back, and sitting down again, while timing how long it takes to complete the task. The TUG test is used to evaluate people who have balance impairments due to various conditions, such as aging, stroke, Parkinson's disease, or vestibular disorders. The TUG test also has some limitations. The reliability of this test is 0.97 to o.99.
Modified Barthel index
Time frame: 4 weeks
The Barthel Index is a scale used to measure an individual's ability to perform activities of daily living. The Reliability of MBI is 0.73 to 0.77. It is often employed in healthcare settings to evaluate functional independence, guide rehabilitation plans, and monitor progress in patients. there are 10 items, each scored from 0 to 2 or 3 points, The total score ranges from 0 to 20 or 25, with higher scores indicating greater independence. The 10 items are: Bowel control Bladder control Grooming Toilet using Feeding Transfer (bed to chair and back) Mobility Dressing Stairs Bathing
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 23 Jan 2025.
- Background: PubMed 37427630Mazhar T, Jameel A, Sharif F, Asghar M. Effects of conventional physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait, and function in patients with Parkinson's disease. J Pak Med Assoc. 2023 Jun;73(6):1280-1283. doi: 10.47391/JPMA.6710.
- Background: PubMed 29706993Giardini M, Nardone A, Godi M, Guglielmetti S, Arcolin I, Pisano F, Schieppati M. Instrumental or Physical-Exercise Rehabilitation of Balance Improves Both Balance and Gait in Parkinson's Disease. Neural Plast. 2018 Mar 7;2018:5614242. doi: 10.1155/2018/5614242. eCollection 2018.
- Background: PubMed 33362441Alexandre de Assis IS, Luvizutto GJ, Bruno ACM, Sande de Souza LAP. The Proprioceptive Neuromuscular Facilitation Concept in Parkinson Disease: A Systematic Review and Meta-Analysis. J Chiropr Med. 2020 Sep;19(3):181-187. doi: 10.1016/j.jcm.2020.07.003. Epub 2020 Dec 15.
- Background: PubMed 31607351Mak MKY, Wong-Yu ISK. Exercise for Parkinson's disease. Int Rev Neurobiol. 2019;147:1-44. doi: 10.1016/bs.irn.2019.06.001. Epub 2019 Jun 27.
- Background: PubMed 31234571Pelicioni PHS, Menant JC, Latt MD, Lord SR. Falls in Parkinson's Disease Subtypes: Risk Factors, Locations and Circumstances. Int J Environ Res Public Health. 2019 Jun 23;16(12):2216. doi: 10.3390/ijerph16122216.
- Background: PubMed 30975519Mirelman A, Bonato P, Camicioli R, Ellis TD, Giladi N, Hamilton JL, Hass CJ, Hausdorff JM, Pelosin E, Almeida QJ. Gait impairments in Parkinson's disease. Lancet Neurol. 2019 Jul;18(7):697-708. doi: 10.1016/S1474-4422(19)30044-4. Epub 2019 Apr 8.
- Background: PubMed 30584154Nonnekes J, Nieuwboer A. Towards Personalized Rehabilitation for Gait Impairments in Parkinson's Disease. J Parkinsons Dis. 2018;8(s1):S101-S106. doi: 10.3233/JPD-181464.
- 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.
Arnab Altaf, MSDPT 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 PNF exercises and Body weight supported treadmill gait training and Body weight supported treadmill gait training and Routine physical therapy in people with Parkinson Disease (PD) and Proprioceptive Neuromuscular Facilitation, 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 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 23 Jan 2025. 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?
Berg balance scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789133, which also lists 7 linked publications.
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 23 Jan 2025.