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

NCT05154552 | Completed

• 1 other identifier: IRB-UOL-FAHS/986/2021
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Parkinson' disease; Proprioceptive Neuromuscular Facilitation; Freezing of gait; Berg Balance Scale; Functional Independence Measure; Freezing of Gait Questionnaire

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Other: Routine physical therapy

Interventions

Proprioceptive Neuromuscular Facilitation 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.

group A/ routine physical therapy and PNF

Routine physical therapy 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 A/ routine physical therapy and PNF; group B/ routine physical therapy

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (2)

Sir Ganga Raam Hospital

Lahore, Punjab Province, 75500, Pakistan

Location

University of Lahore Teaching Hospital

Lahore, Punjab Province, 75500, Pakistan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tahzeeb Mazhar, MSPTN

  University of Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 13, 2021
• Study Start: November 5, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

PA (2)