Parkinson DiseaseNCT05154552
Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease
A study testing Proprioceptive Neuromuscular Facilitation and Routine physical therapy in people with Parkinson Disease, run by University of Lahore at 2 sites in Pakistan.
Trial summary
Objective of this study is to compare the effectiveness of routine physical therapy with and without Proprioceptive Neuromuscular Facilitation on Balance, gait and function in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Proprioceptive Neuromuscular Facilitation and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesPakistan
- Study dates
- 5 Nov 2021to 3 Mar 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients of age between 60 and 85 years, diagnosed with Parkinson's disease by a neurologist.
- Patients with Hoehn and Yahr stages 1-3.
- Patients with a stable drug program and acclimated to their current medication use for at least 2 weeks.
Who cannot join
- Cognitive deficits (scores of <26 on the Mini-Mental State Examination).
- Moderate or severe depression (scores of >17 on the Beck Depression Inventory).
- Patients with neurological diseases, arthrosis, or total hip joint replacement.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Sir Ganga Raam Hospital
Lahore, Punjab Province, 75500
University of Lahore Teaching Hospital
Lahore, Punjab Province, 75500
About this study
Official title: Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease.
Objective of this study is to compare the effectiveness of routine physical therapy with and without Proprioceptive Neuromuscular Facilitation on Balance, gait and function in patients with Parkinson's disease.
Alternate hypothesis:
There will be a difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.
Null hypothesis:
There will be no difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.
Read the detailed description
It will be a prospectively registered, parallel designed, single blinded randomized controlled trial with concealed allocation, conducted in University of Lahore Teaching Hospital and Sir Ganga Raam hospital, Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.consent form will be signed by all eligible participants. Eligibility of participants will be confirmed by the physiotherapist of research team before randomization. After baseline assessment, eligible patients will be randomly allocated(in a 1:! ratio) in two groups( group A and group B). Fish bowl method of randomization will be used and will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis.
Randomization assignments will be kept in opaque, sealed envelopes for concealment of group allocation and will be unsealed by researcher after baseline testing. Researchers who assess outcomes or will do data analyses will be masked to group allocation.The calculated sample size is 32 (16 in each group), after adding 20% dropout the sample size will be 32+6=38, 19 patients in each group.(statistical power 80% and alpha level of 5%).
- Conditions
- Parkinson Disease
- Being tested
- Proprioceptive Neuromuscular Facilitation, Routine physical therapy
- Keywords
- Parkinson' disease, Proprioceptive Neuromuscular Facilitation, Freezing of gait, Berg Balance Scale, Functional Independence Measure, Freezing of Gait Questionnaire
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
Proprioceptive Neuromuscular Facilitation (PNF) is a more advanced form of flexibility training, which involves both the stretching and contracting of the muscle group being targeted. PNF stretching is one of the most effective forms of stretching for improving flexibility and increasing range of motion.
Routine physical therapyOther
Routine physiotherapy in Parkinson Disease will be administered according to the European Physiotherapy guidelines for Parkinson Disease and focused on the following areas based on the stage of the disease:Self-management support, prevention of inactivity and fear of falls, maintaining or improving global motor activities, improvement of physical performance, and improvement in the ability to perform transfer, balance, gait, and manual activities, reduce pain, and delay the onset of physical limitations.
Other exercises include:
- Range of motion exercises
- Stretching exercises
- Upper and lower limb strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| group A/ routine physical therapy and PNF | Experimental | In group A, PNF based gait training (15 minutes) and conventional physical therapy (45 minutes) will be performed.
PNF exercises involved PNF pelvic patterns (pelvic interior elevation and posterior depression), PNF lower extremity D1 Flexion and PNF lower extremity D1 extension (Unilateral during 1st to 3rd week and bilateral from 4th week onwards). Exercises will progress from rhythmic initiation and then progress to slow reversal and agonistic reversal up to 6th week of therapy and continues until 12th week. Each exercise will be repeated for 10 to 20 times.
Conventional physiotherapy will be administered according to the European Physiotherapy guidelines for Parkinson's disease.
Other exercises include:
1. Range of motion exercises
2. Stretching exercises
3. Upper and lower limb strengthening exercises Receives: Other: Proprioceptive Neuromuscular Facilitation; Other: Routine physical therapy |
| group B/ routine physical therapy | Active comparator | Conventional physical therapy (45 minute session) will be performed in group B.Conventional physiotherapy will be administered according to the European Physiotherapy guidelines for Parkinson disease.
Other exercises include:
1. Range of motion exercises
2. Stretching exercises
3. Upper and lower limb strengthening exercises Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.)
It is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. It consist of a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task. Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
Measured: the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.
The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)
It is used to assess freezing of gait severity in patients with Parkinson's disease. It consists of a 6-item questionnaire. A 5-point scale is used to mark scores. Zero (absence of symptoms) to 4 (most severe), is used for each item to rank severity of symptoms.
Measured: the change in freezing of gait in individuals at baseline, 6th and 12th week
Functional Independence Measure (FIM) (to assess the change in ability to do activities of daily living at baseline, 6th and 12th week.)
It is used to assess the ability of patients to do activities of daily living. It consist of 18-item, clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication, and cognition. Total score for FIM will be a value between 18 and 126. Higher the score, more independent the patient is.
Measured: the change in ability to do activities of daily living at baseline, 6th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start5 Nov 2021
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tahzeeb Mazhar, MSPTN, Principal investigator, University of Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154552
- Sponsor's protocol ID
- IRB-UOL-FAHS/986/2021
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05154552
- Acronym / sponsor ID
- IRB-UOL-FAHS/986/2021
- Conditions
- Parkinson Disease
- Keywords
- Parkinson' disease, Proprioceptive Neuromuscular Facilitation, Freezing of gait, Berg Balance Scale, Functional Independence Measure, Freezing of Gait Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 13 Dec 2021 (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.
Objective of this study is to compare the effectiveness of routine physical therapy with and without Proprioceptive Neuromuscular Facilitation on Balance, gait and function in patients with Parkinson's disease.
Alternate hypothesis:
There will be a difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.
Null hypothesis:
There will be no difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.
Detailed description
It will be a prospectively registered, parallel designed, single blinded randomized controlled trial with concealed allocation, conducted in University of Lahore Teaching Hospital and Sir Ganga Raam hospital, Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.consent form will be signed by all eligible participants. Eligibility of participants will be confirmed by the physiotherapist of research team before randomization. After baseline assessment, eligible patients will be randomly allocated(in a 1:! ratio) in two groups( group A and group B). Fish bowl method of randomization will be used and will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis.
Randomization assignments will be kept in opaque, sealed envelopes for concealment of group allocation and will be unsealed by researcher after baseline testing. Researchers who assess outcomes or will do data analyses will be masked to group allocation.The calculated sample size is 32 (16 in each group), after adding 20% dropout the sample size will be 32+6=38, 19 patients in each group.(statistical power 80% and alpha level of 5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A/ routine physical therapy and PNF | Experimental | Other: Proprioceptive Neuromuscular Facilitation, Other: Routine physical therapyIn group A, PNF based gait training (15 minutes) and conventional physical therapy (45 minutes) will be performed. PNF exercises involved PNF pelvic patterns (pelvic interior elevation and posterior depression), PNF lower extremity D1 Flexion and PNF lower extremity D1 extension (Unilateral during 1st to 3rd week and bilateral from 4th week onwards). Exercises will progress from rhythmic initiation and then progress to slow reversal and agonistic reversal up to 6th week of therapy and continues until 12th week. Each exercise will be repeated for 10 to 20 times. Conventional physiotherapy will be administered according to the European Physiotherapy guidelines for Parkinson's disease. Other exercises include: 1. Range of motion exercises 2. Stretching exercises 3. Upper and lower limb strengthening exercises |
| group B/ routine physical therapy | Active comparator | Other: Routine physical therapyConventional physical therapy (45 minute session) will be performed in group B.Conventional physiotherapy will be administered according to the European Physiotherapy guidelines for Parkinson disease. Other exercises include: 1. Range of motion exercises 2. Stretching exercises 3. Upper and lower limb strengthening exercises |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients of age between 60 and 85 years, diagnosed with Parkinson's disease by a neurologist.
- Patients with Hoehn and Yahr stages 1-3.
- Patients with a stable drug program and acclimated to their current medication use for at least 2 weeks.
Key exclusion criteria (3 listed)
- Cognitive deficits (scores of <26 on the Mini-Mental State Examination).
- Moderate or severe depression (scores of >17 on the Beck Depression Inventory).
- Patients with neurological diseases, arthrosis, or total hip joint replacement.
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 |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationProprioceptive Neuromuscular Facilitation (PNF) is a more advanced form of flexibility training, which involves both the stretching and contracting of the muscle group being targeted. PNF stretching is one of the most effective forms of stretching for improving flexibility and increasing range of motion. | Other | group A/ routine physical therapy and PNF |
| Routine physical therapyRoutine physiotherapy in Parkinson Disease will be administered according to the European Physiotherapy guidelines for Parkinson Disease and focused on the following areas based on the stage of the disease:Self-management support, prevention of inactivity and fear of falls, maintaining or improving global motor activities, improvement of physical performance, and improvement in the ability to perform transfer, balance, gait, and manual activities, reduce pain, and delay the onset of physical limitations. Other exercises include: 1. Range of motion exercises 2. Stretching exercises 3. Upper and lower limb strengthening exercises | Other | group A/ routine physical therapy and PNF, group B/ routine physical therapy |
Primary outcome
Berg balance scale (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.)
Time frame: the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.
It is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. It consist of a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task. Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)
Time frame: the change in freezing of gait in individuals at baseline, 6th and 12th week
It is used to assess freezing of gait severity in patients with Parkinson's disease. It consists of a 6-item questionnaire. A 5-point scale is used to mark scores. Zero (absence of symptoms) to 4 (most severe), is used for each item to rank severity of symptoms.
Functional Independence Measure (FIM) (to assess the change in ability to do activities of daily living at baseline, 6th and 12th week.)
Time frame: the change in ability to do activities of daily living at baseline, 6th and 12th week
It is used to assess the ability of patients to do activities of daily living. It consist of 18-item, clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication, and cognition. Total score for FIM will be a value between 18 and 126. Higher the score, more independent the patient is.
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 18 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Tahzeeb Mazhar, MSPTN principal investigator
University of Lahore, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation and Routine physical therapy in people with Parkinson Disease, run by University of Lahore at 2 sites 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 3 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.) (time frame: the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.). 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?
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 18 Mar 2022.