Parkinson DiseaseNCT05490784
Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients
A study testing Lee Silverman Voice Treatment BIG and conventional treatment in people with Parkinson Disease and Motor Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease, Motor Disorders, Balance; Distorted
- What is being tested?
- Lee Silverman Voice Treatment BIG and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 20 Aug 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I, II, III Parkinson's patients on Hoehn \&;Yahr classification
- Able to walk without assistive devices
- Stable medication 4 weeks prior to and during study
Who cannot join
- Patients with depression or dementia
- Disabling bradykinesia to make sure patients are efficient to engage and cooperate in conventional physical therapy
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients
Read the detailed description
This study will be conducted to compare the effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on dynamic balance in patients of PD. Patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation center, National Hospital Lahore. Dynamic gait index will be used as data collection tool to test dynamic balance of patients. Patients will be allocated to intervention groups by randomization. After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.
- Conditions
- Parkinson Disease, Motor Disorders, Balance; Distorted
- Being tested
- Lee Silverman Voice Treatment BIG, conventional treatment
- Keywords
- Parkinson Disease, Balance; Distorted, Motor Disorders
- Medical subject headings
- Parkinson Disease, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lee Silverman Voice Treatment BIGOther
Patients assigned to experimental group will get Lee Silverman Voice Treatment BIG along with conventional treatment.
conventional treatmentOther
patients in this group will get conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability.
| Study group | Role | What they receive |
|---|---|---|
| Lee Silverman Voice Treatment big with conventional treatment | Experimental | Lee Silverman Voice Treatment big with conventional treatment Receives: Other: Lee Silverman Voice Treatment BIG |
| control group | Active comparator | Patients assigned to control group received conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability. Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
Dynamic gait index assesses postural stability, gait, and balance. It evaluates various gait- related tasks with challenging situations such as head turn, speed change, obstacles and stairs climbing.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jan 2022
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Model description
- total 26 participants will be randomly assigned to experimental group (Lee Silverman Voice Treatment BIG along with conventional therapy) and control group( conventional treatment)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490784
- Sponsor's protocol ID
- REC/RCR & AHS/21/0253
- Status last verified
- Nov 2022
- First submitted
- 4 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oguz S, Erturk G, Polat MG, Apaydin H. The effect of kinesiophobia on physical activity, balance, and fear of falling in patients with Parkinson's disease. Physiother Theory Pract. 2023 Apr;39(4):865-872. doi: 10.1080/09593985.2022.2028325. Epub 2022 Jan 18.
PubMed 35042438Fleming Walsh S, Balster C, Chandler A, Brown J, Boehler M, O'Rear S. LSVT BIG(R) and long-term retention of functional gains in individuals with Parkinson's disease. Physiother Theory Pract. 2022 May;38(5):629-636. doi: 10.1080/09593985.2020.1780655. Epub 2020 Jun 17.
PubMed 33969801Schaible F, Maier F, Buchwitz TM, Schwartz F, Hoock M, Schonau E, Libuda M, Hordt A, van Eimeren T, Timmermann L, Eggers C. Effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on non-motor and motor symptoms in Parkinson's disease: a randomized controlled study comparing three exercise models. Ther Adv Neurol Disord. 2021 Feb 18;14:1756286420986744. doi: 10.1177/1756286420986744. eCollection 2021.
PubMed 33680093Tremblay C, Abbasi N, Zeighami Y, Yau Y, Dadar M, Rahayel S, Dagher A. Sex effects on brain structure in de novo Parkinson's disease: a multimodal neuroimaging study. Brain. 2020 Oct 1;143(10):3052-3066. doi: 10.1093/brain/awaa234.
PubMed 32980872
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05490784
- Acronym / sponsor ID
- REC/RCR & AHS/21/0253
- Conditions
- Parkinson Disease, Motor Disorders, Balance; Distorted
- Keywords
- Parkinson Disease, Balance; Distorted, Motor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 8 Aug 2022 (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.
To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients
Detailed description
This study will be conducted to compare the effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on dynamic balance in patients of PD. Patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation center, National Hospital Lahore. Dynamic gait index will be used as data collection tool to test dynamic balance of patients. Patients will be allocated to intervention groups by randomization. After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- total 26 participants will be randomly assigned to experimental group (Lee Silverman Voice Treatment BIG along with conventional therapy) and control group( conventional treatment)
| Arm | Type | Receives |
|---|---|---|
| Lee Silverman Voice Treatment big with conventional treatment | Experimental | Other: Lee Silverman Voice Treatment BIGLee Silverman Voice Treatment big with conventional treatment |
| control group | Active comparator | Other: conventional treatmentPatients assigned to control group received conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage I, II, III Parkinson's patients on Hoehn \&;Yahr classification
- Able to walk without assistive devices
- Stable medication 4 weeks prior to and during study
Key exclusion criteria (2 listed)
- Patients with depression or dementia
- Disabling bradykinesia to make sure patients are efficient to engage and cooperate in conventional physical therapy
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 |
|---|---|---|
| Lee Silverman Voice Treatment BIGPatients assigned to experimental group will get Lee Silverman Voice Treatment BIG along with conventional treatment. | Other | Lee Silverman Voice Treatment big with conventional treatment |
| conventional treatmentpatients in this group will get conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability. | Other | control group |
Primary outcome
Dynamic Gait Index
Time frame: 9 months
Dynamic gait index assesses postural stability, gait, and balance. It evaluates various gait- related tasks with challenging situations such as head turn, speed change, obstacles and stairs climbing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Background: PubMed 35042438Oguz S, Erturk G, Polat MG, Apaydin H. The effect of kinesiophobia on physical activity, balance, and fear of falling in patients with Parkinson's disease. Physiother Theory Pract. 2023 Apr;39(4):865-872. doi: 10.1080/09593985.2022.2028325. Epub 2022 Jan 18.
- Background: PubMed 33969801Fleming Walsh S, Balster C, Chandler A, Brown J, Boehler M, O'Rear S. LSVT BIG(R) and long-term retention of functional gains in individuals with Parkinson's disease. Physiother Theory Pract. 2022 May;38(5):629-636. doi: 10.1080/09593985.2020.1780655. Epub 2020 Jun 17.
- Background: PubMed 33680093Schaible F, Maier F, Buchwitz TM, Schwartz F, Hoock M, Schonau E, Libuda M, Hordt A, van Eimeren T, Timmermann L, Eggers C. Effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on non-motor and motor symptoms in Parkinson's disease: a randomized controlled study comparing three exercise models. Ther Adv Neurol Disord. 2021 Feb 18;14:1756286420986744. doi: 10.1177/1756286420986744. eCollection 2021.
- Background: PubMed 32980872Tremblay C, Abbasi N, Zeighami Y, Yau Y, Dadar M, Rahayel S, Dagher A. Sex effects on brain structure in de novo Parkinson's disease: a multimodal neuroimaging study. Brain. 2020 Oct 1;143(10):3052-3066. doi: 10.1093/brain/awaa234.
- Individual participant dataSharing planned: No
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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.
zeest hashmi, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lee Silverman Voice Treatment BIG and conventional treatment in people with Parkinson Disease and Motor Disorders, run by Riphah International University at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490784, which also lists 4 linked publications.
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 9 Nov 2022.