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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Proprioceptive Neuromuscular Facilitation; Other: Routine physical therapy

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 75500
      • Sir Ganga Raam Hospital
    • Lahore, Punjab, Pakistan, 75500
      • University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: Range of motion exercises; Stretching exercises; Upper and lower limb strengthening exercises	Other: 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.; 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: Range of motion exercises; Stretching exercises; Upper and lower limb strengthening exercises
Active Comparator: 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: Range of motion exercises; Stretching exercises; Upper and lower limb strengthening exercises	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: Range of motion exercises; Stretching exercises; Upper and lower limb strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	the change in ability to do activities of daily living at baseline, 6th and 12th week

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: Tahzeeb Mazhar, MSPTN, University of Lahore, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Freezing of gait; Proprioceptive Neuromuscular Facilitation; Parkinson' disease; Berg Balance Scale; Functional Independence Measure; Freezing of Gait Questionnaire
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: IRB-UOL-FAHS/986/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No