Clinical trial NCT05907148: Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
Official title: Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Sensory Integration Training
Berg Balance Scale
Balance
Activities-Specific Balance Confidence Scale
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Objective of this research was to study the effectiveness of sensory integration training on balance and confidence in patients with Parkinson's disease.

Null Hypothesis:

Sensory integration training and conventional balance training have no significant difference in improving balance and confidence of patients with Parkinson's disease.

Alternative Hypothesis:

Sensory integration training and conventional balance training have a significant difference in improving balance and confidence in patients with Parkinson's disease.

Detailed description: The study design will be randomized controlled clinical trial. Patients who fulfill the inclusion criteria will be identified by individual physiotherapist and will be enrolled for particular study. A sample size of 46 patients will be taken in this study by expecting a mean change 10.42 using 80% power of study and 95% level of significance and 20% dropout will also be included. So each group contains 23 participants.

The study will be single blinded. The outcome assessor will be unaware of the treatment given to both groups. Sample will be collected through simple random sampling technique, and randomization sequencing will be generated with help of lottery. After selection the sample patients will be divided into two groups, allocation concealment will be ensured by using sealed envelopes. Group A will be given conventional balance training along with routine physical therapy without sensory integration and Group B will be given sensory integration physical therapy along with routine physical therapy. Group A will be called control group and Group B will be called experimental group. Every patient has to pick up an envelope which will be placed in patient's file which later will be opened by the researcher who will provide patient treatment accordingly.

Eligibility criteria: Inclusion Criteria:

* Male and female patients diagnosed by a neurologist with Parkinson's disease.
* Patients having BBS score between 21-40
* At least 6 months post neurological Sensory/Motor deficit patient.
* Age between 30 -65 years.
* Ability to maintain standing position without aids for at least 5 minutes.
* Normal vision
* No severe systemic disorders
* An ability to understand and perform the test

Exclusion Criteria:

* Patients with other existing neuromuscular disorders or medical conditions that substantially influences their gait and balance performance
* Neuropathy patients
* Vestibular disorders, paroxysmal vertigo.
* Presence of orthopedic conditions involving the lower limbs.
* Patients with psychiatric disorders.
* Pregnant patients.

Primary outcomes:
measure: Berg Balance Scale (BBS):
timeFrame: the change in the ability to balance in individual at baseline, 6th and 12th week
measure: Activities-specific Balance Confidence Scale (ABC):
timeFrame: the change in the ability to balance in individual at baseline, 6th and 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: ganga Raam Hopital
state: Punjab
city: Lahore
country: Pakistan
facility: the Univerity of Lahore Teaching hospital
state: Punjab
Study officials:
References: