Parkinson DiseaseNCT05506813
Comparative Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients
A study testing cognitive training and conventional training and motor dual task training along with conventional therapy in people with Parkinson Disease and Balance; Distorted, run by Riphah International University at 1 site in Pakistan.
Trial summary
To Compare Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease, Balance; Distorted, Postural; Defect
- What is being tested?
- cognitive training and conventional training and motor dual task training along with conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A stage I-II-III Hoehn and Yahr scale consultant neurologist's diagnosis of Parkinson's disease
- A stable medication schedule both before and during the trial period
- can walk without assistive aid
Who cannot join
- Other neurological conditions in additions to Parkinson's disease such as CVA, Head injuries, Trauma
- Any Musculoskeletal condition e.g., total knee replacement surgery and rheumatoid arthritis
- Sensory impairments (vestibular dysfunctions)
Trial locations and contacts
1 site in 1 country.
About this study
To Compare Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients
Read the detailed description
This study will be conducted to compare the Comparative Effect of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients. total 20 Patients will be recruited according to the inclusion criteria and data will be collected from the Riphah Rehabilitation center Lahore, Muhammadi Medical trust hospital Lahore. Time Up and Go test (TUG) Parkinsons disease Questionnaire 39 (PDQ-39) will be used as data collection tool. To assess the balance and quality of life in parkinson's patients. Patients will be allocated to intervention group by randomization. After approval from ethical committee, data collection will be started and informed consent will be taken from all patients
- Conditions
- Parkinson Disease, Balance; Distorted, Postural; Defect
- Being tested
- cognitive training and conventional training, motor dual task training along with conventional therapy
- Keywords
- Parkinson Disease, Balance; Distorted, Postural; Defect
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive training and conventional trainingOther
cognitive training along with conventional therapy
motor dual task training along with conventional therapyOther
motor dual task training along with conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | cognitive training and conventional training Receives: Other: cognitive training and conventional training |
| control group | Active comparator | motor dual task training and conventional training Receives: Other: motor dual task training along with conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time up and go test
In time up and go test instruct patient stand up and then walking 3 meters far then rotate and come back. Therapist noted the whole procedure time
Measured: 9 months
Parkinson Disease Questionnaire-39 (PDQ-39).
Parkinson Disease Questionnaire-39 (PDQ-39).The tool carried out 39 items. The tool carried out 39 items. For each domain, five answer shows that every part score is 0 (good) to 100 (critical). Decreased scores showed better quality of life
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 posted18 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 (3)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 20 Participants will be divided in two groups. In group A patients will receive cognitive training along with conventional therapy. while in Group B Participants will receive motor dual task training along with conventional therapy.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05506813
- Sponsor's protocol ID
- REC/RCR & AHS/21/0256
- Status last verified
- Nov 2022
- First submitted
- 17 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bordignon A, Devita M, Sergi G, Coin A. "Cerebellar cognitive reserve": a possible further area of investigation. Aging Clin Exp Res. 2021 Oct;33(10):2883-2886. doi: 10.1007/s40520-021-01795-1. Epub 2021 Feb 17. No abstract available.
PubMed 33595777Onder H, Ozyurek O. The impact of distinct cognitive dual-tasks on gait in Parkinson's disease and the associations with the clinical features of Parkinson's disease. Neurol Sci. 2021 Jul;42(7):2775-2783. doi: 10.1007/s10072-020-04874-9. Epub 2020 Nov 4.
PubMed 33150515Bouscary A, Quessada C, Rene F, Spedding M, Turner BJ, Henriques A, Ngo ST, Loeffler JP. Sphingolipids metabolism alteration in the central nervous system: Amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. Semin Cell Dev Biol. 2021 Apr;112:82-91. doi: 10.1016/j.semcdb.2020.10.008. Epub 2020 Nov 5.
PubMed 33160824
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
- Comparative Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05506813
- Acronym / sponsor ID
- REC/RCR & AHS/21/0256
- Conditions
- Parkinson Disease, Balance; Distorted, Postural; Defect
- Keywords
- Parkinson Disease, Balance; Distorted, Postural; Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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
- 18 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 Compare Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients
Detailed description
This study will be conducted to compare the Comparative Effect of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients. total 20 Patients will be recruited according to the inclusion criteria and data will be collected from the Riphah Rehabilitation center Lahore, Muhammadi Medical trust hospital Lahore. Time Up and Go test (TUG) Parkinsons disease Questionnaire 39 (PDQ-39) will be used as data collection tool. To assess the balance and quality of life in parkinson's patients. Patients will be allocated to intervention group 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
- None (open label)
- Number of arms
- 2
- Model description
- total 20 Participants will be divided in two groups. In group A patients will receive cognitive training along with conventional therapy. while in Group B Participants will receive motor dual task training along with conventional therapy.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: cognitive training and conventional trainingcognitive training and conventional training |
| control group | Active comparator | Other: motor dual task training along with conventional therapymotor dual task training and conventional training |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A stage I-II-III Hoehn and Yahr scale consultant neurologist's diagnosis of Parkinson's disease
- A stable medication schedule both before and during the trial period
- can walk without assistive aid
Key exclusion criteria (3 listed)
- Other neurological conditions in additions to Parkinson's disease such as CVA, Head injuries, Trauma
- Any Musculoskeletal condition e.g., total knee replacement surgery and rheumatoid arthritis
- Sensory impairments (vestibular dysfunctions)
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 |
|---|---|---|
| cognitive training and conventional trainingcognitive training along with conventional therapy | Other | experimental group |
| motor dual task training along with conventional therapymotor dual task training along with conventional therapy | Other | control group |
Primary outcome
time up and go test
Time frame: 9 months
In time up and go test instruct patient stand up and then walking 3 meters far then rotate and come back. Therapist noted the whole procedure time
Parkinson Disease Questionnaire-39 (PDQ-39).
Time frame: 9 months
Parkinson Disease Questionnaire-39 (PDQ-39).The tool carried out 39 items. The tool carried out 39 items. For each domain, five answer shows that every part score is 0 (good) to 100 (critical). Decreased scores showed better quality of life
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 33595777Bordignon A, Devita M, Sergi G, Coin A. "Cerebellar cognitive reserve": a possible further area of investigation. Aging Clin Exp Res. 2021 Oct;33(10):2883-2886. doi: 10.1007/s40520-021-01795-1. Epub 2021 Feb 17. No abstract available.
- Background: PubMed 33150515Onder H, Ozyurek O. The impact of distinct cognitive dual-tasks on gait in Parkinson's disease and the associations with the clinical features of Parkinson's disease. Neurol Sci. 2021 Jul;42(7):2775-2783. doi: 10.1007/s10072-020-04874-9. Epub 2020 Nov 4.
- Background: PubMed 33160824Bouscary A, Quessada C, Rene F, Spedding M, Turner BJ, Henriques A, Ngo ST, Loeffler JP. Sphingolipids metabolism alteration in the central nervous system: Amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. Semin Cell Dev Biol. 2021 Apr;112:82-91. doi: 10.1016/j.semcdb.2020.10.008. Epub 2020 Nov 5.
- 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 cognitive training and conventional training and motor dual task training along with conventional therapy in people with Parkinson Disease and Balance; Distorted, 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 3 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?
time up and go test (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT05506813, which also lists 3 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.