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

NCT ID: NCT05907148

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2023-10-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Routine Physical therapy along with Coordination exercises

The Control group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training. Active joint mobilization will be carried out with the patient in the supine, prone (if possible), or sitting positions. Muscle stretching will be carried out mainly in the supine, prone (if possible), and standing positions. Motor coordination exercises will be carried out in a supine position, sitting and standing positions.

Group Type: ACTIVE_COMPARATOR

Routine physical therapy

Intervention Type: OTHER

It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training

General coordination exercise

Intervention Type: OTHER

In supine lying:

1. Patients are told to place heel of one leg on shin or knee of the other leg,

2. Patient bends one leg and extends the other leg like bicycling motion.

3. Flexing one leg while extending other leg

4. Flexing and extending of one leg while abduction and adduction of other leg.

In sitting:

1. Patient performs marching without backrest or back support,

2. Patient reaches forward and sideways with arms

3. Rotation of trunk with physioball in hand without back support.

4. Patient reaches with legs to marked point in sitting.

In standing:

Patient performs 10 repetitions of

1. Clock Reach

2. Side Leg Raises

3. Leg Swings and

4. Ball catch and throw

sensory Integration training group along with Routine physical therapy

experimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.

Group Type: EXPERIMENTAL

Sensory integration training

Intervention Type: OTHER

Sitting position:

1. Sit in a chair without a backrest while the feet on firm surface. without backrest while the feet on soft surface.

2. Sit on a ball while the feet on firm surface. while feet on soft surface.

3. 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.

4. 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.

5. Perform bipedal standing on a firm surface. on a soft surface.

6. Perform a semi-tandem stance on firm surface. on soft surface.

7. Walk forward on firm surface. on soft surface.

8. Walk forward on firm surface, cross obstacle, and continue to walk.

9. Walk forward on the soft surface, cross obstacle, and continue to walk.

Routine physical therapy

Intervention Type: OTHER

It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training

Interventions

Sensory integration training

Sitting position:

1. Sit in a chair without a backrest while the feet on firm surface. without backrest while the feet on soft surface.

2. Sit on a ball while the feet on firm surface. while feet on soft surface.

3. 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.

4. 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.

5. Perform bipedal standing on a firm surface. on a soft surface.

6. Perform a semi-tandem stance on firm surface. on soft surface.

7. Walk forward on firm surface. on soft surface.

8. Walk forward on firm surface, cross obstacle, and continue to walk.

9. Walk forward on the soft surface, cross obstacle, and continue to walk.

Intervention Type: OTHER

Routine physical therapy

It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training

Intervention Type: OTHER

General coordination exercise

In supine lying:

1. Patients are told to place heel of one leg on shin or knee of the other leg,

2. Patient bends one leg and extends the other leg like bicycling motion.

3. Flexing one leg while extending other leg

4. Flexing and extending of one leg while abduction and adduction of other leg.

In sitting:

1. Patient performs marching without backrest or back support,

2. Patient reaches forward and sideways with arms

3. Rotation of trunk with physioball in hand without back support.

4. Patient reaches with legs to marked point in sitting.

In standing:

Patient performs 10 repetitions of

1. Clock Reach

2. Side Leg Raises

3. Leg Swings and

4. Ball catch and throw

Intervention Type: OTHER

Other Intervention Names

consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ganga Raam Hopital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

the Univerity of Lahore Teaching hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Momna Asghar, MsPTN

Role: CONTACT

momna2april@gnmail.com

+92336249488

Facility Contacts

Arooj Munawar, PHD

Role: primary

arooj.munawar@uipt.uol.edu.pk

momna asghar, mspt

Role: primary

momna2april@gmail.com

+923047487795

Other Identifiers

REC-UOL-367-04-2023

Identifier Type: -

Identifier Source: org_study_id