Parkinson DiseaseNCT05907148
Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
A study testing Sensory integration training, Routine physical therapy and General coordination exercise in people with Parkinson Disease, run by University of Lahore at 2 sites in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Sensory integration training, Routine physical therapy and General coordination exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Nov 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
ganga Raam Hopital
Lahore, Punjab Province
Arooj Munawar, PHD, arooj.munawar@uipt.uol.edu.pk
Abdul Majid shahid
- Recruiting
the Univerity of Lahore Teaching hospital
Lahore, Punjab Province
momna asghar, mspt, +923047487795, momna2april@gmail.com
Abdul Majid shahid, DPT
About this study
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.
Read the 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
- Being tested
- Sensory integration training, Routine physical therapy, General coordination exercise
- Keywords
- Parkinson Disease, Sensory Integration Training, Berg Balance Scale, Balance, Activities-Specific Balance Confidence Scale
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory integration trainingOther
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 therapyOther
Also called consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.
It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training
General coordination exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine physical therapy; Other: 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. Receives: Other: Sensory integration training; Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: the change in the ability to balance in individual at baseline, 6th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Nov 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907148
- Sponsor's protocol ID
- REC-UOL-367-04-2023
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05907148
- Acronym / sponsor ID
- REC-UOL-367-04-2023
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Sensory Integration Training, Berg Balance Scale, Balance, Activities-Specific Balance Confidence Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Physical therapy along with Coordination exercises | Active comparator | Other: Routine physical therapy, Other: General coordination exerciseThe 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. |
| sensory Integration training group along with Routine physical therapy | Experimental | Other: Sensory integration training, Other: Routine physical therapyexperimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory integration trainingSitting 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. | Other | sensory Integration training group along with Routine physical therapy |
| Routine physical therapyAlso: consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training | Other | Routine Physical therapy along with Coordination exercises, sensory Integration training group along with Routine physical therapy |
| General coordination exerciseIn 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 | Other | Routine Physical therapy along with Coordination exercises |
Primary outcome
Berg Balance Scale (BBS):
Time frame: the change in the ability to balance in individual at baseline, 6th and 12th week
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
Activities-specific Balance Confidence Scale (ABC):
Time frame: the change in the ability to balance in individual at baseline, 6th and 12th week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory integration training, Routine physical therapy and General coordination exercise in people with Parkinson Disease, run by University of Lahore at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Momna Asghar, MsPTN (+92336249488, momna2april@gnmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS): (time frame: the change in the ability to balance in individual at baseline, 6th and 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.