Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease

NCT ID: NCT05154552

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2022-03-03

Brief 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.

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%).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A/ routine physical therapy and PNF

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

Group Type: EXPERIMENTAL

Proprioceptive Neuromuscular Facilitation

Intervention Type: OTHER

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 therapy

Intervention Type: OTHER

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:

1. Range of motion exercises

2. Stretching exercises

3. Upper and lower limb strengthening exercises

group B/ routine physical therapy

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

Group Type: ACTIVE_COMPARATOR

Routine physical therapy

Intervention Type: OTHER

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:

1. Range of motion exercises

2. Stretching exercises

3. Upper and lower limb strengthening exercises

Interventions

Proprioceptive Neuromuscular Facilitation

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.

Intervention Type: OTHER

Routine physical therapy

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:

1. Range of motion exercises

2. Stretching exercises

3. Upper and lower limb strengthening exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tahzeeb Mazhar, MSPTN

Role: PRINCIPAL_INVESTIGATOR

University of Lahore, Pakistan

Locations

Sir Ganga Raam Hospital

Lahore, Punjab Province, Pakistan

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB-UOL-FAHS/986/2021

Identifier Type: -

Identifier Source: org_study_id