NCT05907148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

June 7, 2023

Last Update Submit

July 15, 2023

Conditions

Keywords

Parkinson DiseaseSensory Integration TrainingBerg Balance ScaleBalanceActivities-Specific Balance Confidence Scale

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Routine Physical therapy along with Coordination exercises

ACTIVE COMPARATOR

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.

Other: Routine physical therapyOther: General coordination exercise

sensory Integration training group along with Routine physical therapy

EXPERIMENTAL

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

Other: Sensory integration trainingOther: Routine physical therapy

Interventions

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.

sensory Integration training group along with Routine physical therapy

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

Also known as: consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.
Routine Physical therapy along with Coordination exercisessensory Integration training group along with Routine physical therapy

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

Routine Physical therapy along with Coordination exercises

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ganga Raam Hopital

Lahore, Punjab Province, Pakistan

RECRUITING

the Univerity of Lahore Teaching hospital

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Momna Asghar, MsPTN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

November 25, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations