Clinical trial NCT05154552: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson' disease
Proprioceptive Neuromuscular Facilitation
Freezing of gait
Berg Balance Scale
Functional Independence Measure
Freezing of Gait Questionnaire
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

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.

Primary outcomes:
measure: Berg balance scale (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.)
timeFrame: the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.
measure: The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)
timeFrame: the change in freezing of gait in individuals at baseline, 6th and 12th week
measure: Functional Independence Measure (FIM) (to assess the change in ability to do activities of daily living at baseline, 6th and 12th week.)
timeFrame: the change in ability to do activities of daily living at baseline, 6th and 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sir Ganga Raam Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore, Pakistan
name: Tahzeeb Mazhar, MSPTN
role: PRINCIPAL_INVESTIGATOR
References: