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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive Neuromuscular Facilitation
Routine physical therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson' disease, Proprioceptive Neuromuscular Facilitation, Freezing of gait, Berg Balance Scale, Functional Independence Measure, Freezing of Gait Questionnaire

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sir Ganga Raam Hospital
  • University of Lahore Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A/ routine physical therapy and PNF

group B/ routine physical therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2021
Last Updated
March 5, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05154552
Brief Title
Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease
Official Title
Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
March 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson' disease, Proprioceptive Neuromuscular Facilitation, Freezing of gait, Berg Balance Scale, Functional Independence Measure, Freezing of Gait Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A/ routine physical therapy and PNF
Arm Type
Experimental
Arm Description
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
Arm Title
group B/ routine physical therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
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
Intervention Name(s)
Routine physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Berg balance scale (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.)
Description
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.
Time Frame
the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.
Title
The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)
Description
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.
Time Frame
the change in freezing of gait in individuals at baseline, 6th and 12th week
Title
Functional Independence Measure (FIM) (to assess the change in ability to do activities of daily living at baseline, 6th and 12th week.)
Description
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.
Time Frame
the change in ability to do activities of daily living at baseline, 6th and 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahzeeb Mazhar, MSPTN
Organizational Affiliation
University of Lahore, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Ganga Raam Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
75500
Country
Pakistan
Facility Name
University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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