Parkinson DiseaseNCT05854147
Comparison of Effects of TT With and Without Visual and Auditory Cues for Freezing & Gait Patients With PD
A study testing Treadmill Training With Visual and Auditory Cues and Treadmill Training Without Visual and Auditory Cues in people with Parkinson Disease, run by Superior University at 1 site in Pakistan.
Trial summary
To determine the comparison of effects of treadmill training with and without visual and auditory cues for freezing and gait in patients with Parkinson's disease Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Treadmill Training With Visual and Auditory Cues and Treadmill Training Without Visual and Auditory Cues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 Aug 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who are clinically diagnosed with Parkinson Disease. Patients from both genders. Patients with age between 45 years and above. Patient with sufficient visual and auditory capacity to receive given cues will be included
Who cannot join
- Patients with the history of neurological deficit other than PD. Patients who need assistance for walking will be excluded. Patient with any peripheral vascular disease will be excluded. Patient with history of lower limb fracture.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shadman Medical Care
Lahore, Punjab Province
About this study
Official title: Comparison of Effects of Treadmill Training With and Without Visual and Auditory Cues for Freezing & Gait in Patients With Parkinson's Disease
To determine the comparison of effects of treadmill training with and without visual and auditory cues for freezing and gait in patients with Parkinson's disease
- Conditions
- Parkinson Disease
- Being tested
- Treadmill Training With Visual and Auditory Cues, Treadmill Training Without Visual and Auditory Cues
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill Training With Visual and Auditory CuesDiagnostic test
Comparison of Effects of Treadmill Training With Visual and Auditory Cues
Treadmill Training Without Visual and Auditory CuesDiagnostic test
Comparison of Effects of Treadmill Training Without Visual and Auditory Cues
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Training With Visual and Auditory Cues | Experimental | Not described Receives: Diagnostic Test: Treadmill Training With Visual and Auditory Cues |
| Treadmill Training Without Visual and Auditory Cues | Other | Not described Receives: Diagnostic Test: Treadmill Training Without Visual and Auditory Cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental Examination Scale MME
MMS examination for Freezing and Gait in Patients With Parkinson's Disease
Measured: 6 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 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 Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854147
- Sponsor's protocol ID
- DPT/Batch-Fall18/534
- Status last verified
- May 2023
- First submitted
- 18 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Treadmill Training With and Without Visual and Auditory Cues for Freezing & Gait in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05854147
- Acronym / sponsor ID
- DPT/Batch-Fall18/534
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 May 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.
To determine the comparison of effects of treadmill training with and without visual and auditory cues for freezing and gait in patients with Parkinson's disease
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Training With Visual and Auditory Cues | Experimental | Diagnostic Test: Treadmill Training With Visual and Auditory Cues |
| Treadmill Training Without Visual and Auditory Cues | Other | Diagnostic Test: Treadmill Training Without Visual and Auditory Cues |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who are clinically diagnosed with Parkinson Disease. Patients from both genders. Patients with age between 45 years and above. Patient with sufficient visual and auditory capacity to receive given cues will be included
Key exclusion criteria (1 listed)
- Patients with the history of neurological deficit other than PD. Patients who need assistance for walking will be excluded. Patient with any peripheral vascular disease will be excluded. Patient with history of lower limb fracture.
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 |
|---|---|---|
| Treadmill Training With Visual and Auditory CuesComparison of Effects of Treadmill Training With Visual and Auditory Cues | Diagnostic test | Treadmill Training With Visual and Auditory Cues |
| Treadmill Training Without Visual and Auditory CuesComparison of Effects of Treadmill Training Without Visual and Auditory Cues | Diagnostic test | Treadmill Training Without Visual and Auditory Cues |
Primary outcome
Mini Mental Examination Scale MME
Time frame: 6 Months.
MMS examination for Freezing and Gait in Patients With Parkinson's Disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Training With Visual and Auditory Cues and Treadmill Training Without Visual and Auditory Cues in people with Parkinson Disease, run by Superior 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 1 inclusion and 1 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 11 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zainab Farid, DPT (+923114800889, Dptm-f18-111@superior.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Examination Scale MME (time frame: 6 Months.). 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 11 May 2023.