Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907148
• Other study ID #: REC-UOL-367-04-2023
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2023
• Source: University of Lahore
• Contact: Momna Asghar, MsPTN
• Phone: +92336249488
• Email: momna2april[@]gnmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Sensory integration training
Sitting position: Sit in a chair without a backrest while the feet on firm surface. without backrest while the feet on soft surface. Sit on a ball while the feet on firm surface. while feet on soft surface. Sit in a chair without a backrest with the feet on firm surface and perform sit-to-stand motion. without a backrest with the feet on soft surface and perform sit-to-stand motion. Sit on a ball with the feet on the firm surface and perform sit-to-stand motion. with the feet on the soft surface and perform sit-to-stand motion. Perform bipedal standing on a firm surface. on a soft surface. Perform a semi-tandem stance on firm surface. on soft surface. Walk forward on firm surface. on soft surface. Walk forward on firm surface, cross obstacle, and continue to walk. Walk forward on the soft surface, cross obstacle, and continue to walk.
• Routine physical therapy
It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training
• General coordination exercise
In supine lying: Patients are told to place heel of one leg on shin or knee of the other leg, Patient bends one leg and extends the other leg like bicycling motion. Flexing one leg while extending other leg Flexing and extending of one leg while abduction and adduction of other leg. In sitting: Patient performs marching without backrest or back support, Patient reaches forward and sideways with arms Rotation of trunk with physioball in hand without back support. Patient reaches with legs to marked point in sitting. In standing: Patient performs 10 repetitions of Clock Reach Side Leg Raises Leg Swings and Ball catch and throw

Locations

Country	Name	City	State
Pakistan	ganga Raam Hopital	Lahore	Punjab
Pakistan	the Univerity of Lahore Teaching hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale (BBS):	The BBS is a 14-item validated scale that assesses static and dynamic Balance disorders in individuals with Parkinson's disease (score range, 0-56; higher=better performance). The items explore the ability to sit, stand, lean, turn, and maintain the upright position on one leg. Performance of these tasks depends on central integration processes to select specific response strategies which, in turn, depend on the characteristics of external postural displacement and goals	the change in the ability to balance in individual at baseline, 6th and 12th week
Primary	Activities-specific Balance Confidence Scale (ABC):	This validated and reliable self-reported measure evaluates the patient's perceived level of balance confidence in performing various ambulatory activities without falling or experiencing a sense of instability. The overall score is calculated by adding the item scores and then dividing by the total number of items (score range, 0-100 points per activity; higher=more confident.	the change in the ability to balance in individual at baseline, 6th and 12th week