Parkinson DiseaseNCT05903755
the Effect of Speed Dependent Treadmill Training on Dual Task Performance in Patient With Parkinson's Disease.
A study testing speed dependent treadmill training on moderate speed and speed dependent treadmill training on slow speed in people with Parkinson Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized clinical trail is to identify the impact of treadmill training on walking while doing dual task in patients with Parkinson's disease. By improving walking speed, bradykinesia would be reduced in Parkinson's patients. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- speed dependent treadmill training on moderate speed and speed dependent treadmill training on slow speed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2023to 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to walk on treadmill for 20 min
- Cognitively able to perform required task
- Hoehn and yarn disease stage between I to III.
Who cannot join
- Gait impairment
- Cardiac impairment
- Dementia
- History of fall
- Severe Freezing episodes
- Camptocormia (axial deformity)
- Central or peripheral paresis
- Score less than 20 in mini mental scale.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
General Hospital
Lahore, Punjab Province, 54000
Wajiha Shahid, Phd, 03214885079, wajiha.shahid@riphah.edu.pk
Rahma A. Hameed, MS-NMPT
About this study
Official title: To Understand the Effect of Speed Dependent Treadmill Training on Dual Task Performance in Patient With Parkinson's Disease.
The aim of this randomized clinical trail is to identify the impact of treadmill training on walking while doing dual task in patients with Parkinson's disease. By improving walking speed, bradykinesia would be reduced in Parkinson's patients. So, the findings of this study can help in formulation of future guidelines for management of Parkinson's that will help the clinicians to treat such patients in more efficient way.
Read the detailed description
A RCT that investigated the effect of Treadmill training and physiotherapy in patient with PD using dual tasking as outcome measure.105 Parkinson's disease (PD) patients; these are the subject who received treadmill training and physiotherapy for 14 days. Both intervention helps the patients to enhance the dual task gait velocity.
A study is to identify the effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease to observe the postural stability by incremental speed dependent treadmill training. 54 patient of Parkinson's disease (PD) was randomly allocated in to experimental and control group. 8-week training program was conducted including stretching, Range of motion exercises (ROM), and treadmill training. Walking distance of the training group was gradually increased after 16 training sessions. The training group's scores on the Berg Balance Test, Dynamic Gait Index, and Falls Efficacy Scale dramatically improved after the training program. While the control group, shows no significant improvement in outcome measurements. Specific exercise regimens, such as incremental speed-dependent treadmill training, may increase mobility and minimize fear of fall in-patient with Parkinson's disease.
GAP:The study's relatively small sample size is one of its limitations. There is least work done on speed dependent treadmill training and its effect on dual task performance in-patient with Parkinson's disease. More research is require, to compare various treatment options with incremental speed-dependent treadmill training for Parkinson's disease patients.
- Conditions
- Parkinson Disease
- Being tested
- speed dependent treadmill training on moderate speed, speed dependent treadmill training on slow speed
- Keywords
- Treadmill training, Dual-task performance, Parkinson disease, Physiotherapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speed dependent treadmill training on moderate speedDevice
Experimental group will receive 14 session of speed dependent treadmill training on moderate speed (3 to 6) for 25 minutes along with strengthening, stretching and range of motion exercises.
speed dependent treadmill training on slow speedDevice
Control group will receive 14 session of speed dependent treadmill training on slow speed (1 to 2) for 25 min along with physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| speed dependent treadmill training on moderate speed | Experimental | speed dependent treadmill training on moderate speed along with strengthening, stretching and range of motion exercises. Receives: Device: speed dependent treadmill training on moderate speed |
| speed dependent treadmill training on slow speed | Active comparator | Speed dependent treadmill training on slow speed along with physiotherapy. Receives: Device: speed dependent treadmill training on slow speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson disease rating scale (UPDRS-III)
UPDRS-III is a "Gold standered" for Parkinson disease. It completely access the body function, activities and participation of Parkinson's patient. It consist of 6 session. We will only use Scale's motor component, which consist of 14 item. Each sign and symptom is rated on a 5-point scale (ranging from 0 to 4) higher score represent severe impairment. Highest point represent total or maximal disability.
Measured: 1 day
Secondary outcomes (1)
dual task gait speed test
This test use to access the dual-task gait speed. the gait speed will be measured in single task first, and then in dual task before and after the treatment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start2 Jan 2023
- 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.
- Publications (15)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903755
- Sponsor's protocol ID
- REC/RCR &AHS/23/0223
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek CY, Chang WN, Park BY, Lee KB, Kang KY, Choi MR. Effects of Dual-Task Gait Treadmill Training on Gait Ability, Dual-Task Interference, and Fall Efficacy in People With Stroke: A Randomized Controlled Trial. Phys Ther. 2021 Jun 1;101(6):pzab067. doi: 10.1093/ptj/pzab067.
PubMed 33611557Gassner H, Trutt E, Seifferth S, Friedrich J, Zucker D, Salhani Z, Adler W, Winkler J, Jost WH. Treadmill training and physiotherapy similarly improve dual task gait performance: a randomized-controlled trial in Parkinson's disease. J Neural Transm (Vienna). 2022 Sep;129(9):1189-1200. doi: 10.1007/s00702-022-02514-4. Epub 2022 Jun 13.
PubMed 35697942Cakit BD, Saracoglu M, Genc H, Erdem HR, Inan L. The effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease. Clin Rehabil. 2007 Aug;21(8):698-705. doi: 10.1177/0269215507077269.
PubMed 17846069Verstraeten A, Theuns J, Van Broeckhoven C. Progress in unraveling the genetic etiology of Parkinson disease in a genomic era. Trends Genet. 2015 Mar;31(3):140-9. doi: 10.1016/j.tig.2015.01.004. Epub 2015 Feb 20.
PubMed 25703649Rochester L, Nieuwboer A, Baker K, Hetherington V, Willems AM, Kwakkel G, Van Wegen E, Lim I, Jones D. Walking speed during single and dual tasks in Parkinson's disease: which characteristics are important? Mov Disord. 2008 Dec 15;23(16):2312-8. doi: 10.1002/mds.22219.
PubMed 18816800Plotnik M, Giladi N, Dagan Y, Hausdorff JM. Postural instability and fall risk in Parkinson's disease: impaired dual tasking, pacing, and bilateral coordination of gait during the "ON" medication state. Exp Brain Res. 2011 May;210(3-4):529-38. doi: 10.1007/s00221-011-2551-0. Epub 2011 Jan 30.
PubMed 21279632Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.
PubMed 33177223Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Aug;27(8):675-80. doi: 10.1177/0269215512464702. Epub 2012 Nov 5.
PubMed 23129815Mehrholz J, Kugler J, Storch A, Pohl M, Elsner B, Hirsch K. Treadmill training for patients with Parkinson's disease. Cochrane Database Syst Rev. 2015 Aug 22;(8):CD007830. doi: 10.1002/14651858.CD007830.pub3.
PubMed 26297797Bishnoi A, Lee R, Hu Y, Mahoney JR, Hernandez ME. Effect of Treadmill Training Interventions on Spatiotemporal Gait Parameters in Older Adults with Neurological Disorders: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2022 Feb 28;19(5):2824. doi: 10.3390/ijerph19052824.
PubMed 35270516Mehrholz J, Thomas S, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2017 Aug 17;8(8):CD002840. doi: 10.1002/14651858.CD002840.pub4.
PubMed 28815562Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.
PubMed 30213258Pohl M, Rockstroh G, Ruckriem S, Mrass G, Mehrholz J. Immediate effects of speed-dependent treadmill training on gait parameters in early Parkinson's disease. Arch Phys Med Rehabil. 2003 Dec;84(12):1760-6. doi: 10.1016/s0003-9993(03)00433-7.
PubMed 14669180Aprile I, Conte C, Cruciani A, Pecchioli C, Castelli L, Insalaco S, Germanotta M, Iacovelli C. Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial. J Clin Med. 2022 Aug 31;11(17):5162. doi: 10.3390/jcm11175162.
PubMed 36079092Hulzinga F, Seuthe J, D'Cruz N, Ginis P, Nieuwboer A, Schlenstedt C. Split-Belt Treadmill Training to Improve Gait Adaptation in Parkinson's Disease. Mov Disord. 2023 Jan;38(1):92-103. doi: 10.1002/mds.29238. Epub 2022 Oct 14.
PubMed 36239376
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Understand the Effect of Speed Dependent Treadmill Training on Dual Task Performance in Patient With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05903755
- Acronym / sponsor ID
- REC/RCR &AHS/23/0223
- Conditions
- Parkinson Disease
- Keywords
- Treadmill training, Dual-task performance, Parkinson disease, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 15 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 aim of this randomized clinical trail is to identify the impact of treadmill training on walking while doing dual task in patients with Parkinson's disease. By improving walking speed, bradykinesia would be reduced in Parkinson's patients. So, the findings of this study can help in formulation of future guidelines for management of Parkinson's that will help the clinicians to treat such patients in more efficient way.
Detailed description
A RCT that investigated the effect of Treadmill training and physiotherapy in patient with PD using dual tasking as outcome measure.105 Parkinson's disease (PD) patients; these are the subject who received treadmill training and physiotherapy for 14 days. Both intervention helps the patients to enhance the dual task gait velocity.
A study is to identify the effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease to observe the postural stability by incremental speed dependent treadmill training. 54 patient of Parkinson's disease (PD) was randomly allocated in to experimental and control group. 8-week training program was conducted including stretching, Range of motion exercises (ROM), and treadmill training. Walking distance of the training group was gradually increased after 16 training sessions. The training group's scores on the Berg Balance Test, Dynamic Gait Index, and Falls Efficacy Scale dramatically improved after the training program. While the control group, shows no significant improvement in outcome measurements. Specific exercise regimens, such as incremental speed-dependent treadmill training, may increase mobility and minimize fear of fall in-patient with Parkinson's disease.
GAP:The study's relatively small sample size is one of its limitations. There is least work done on speed dependent treadmill training and its effect on dual task performance in-patient with Parkinson's disease. More research is require, to compare various treatment options with incremental speed-dependent treadmill training for Parkinson's disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| speed dependent treadmill training on moderate speed | Experimental | Device: speed dependent treadmill training on moderate speedspeed dependent treadmill training on moderate speed along with strengthening, stretching and range of motion exercises. |
| speed dependent treadmill training on slow speed | Active comparator | Device: speed dependent treadmill training on slow speedSpeed dependent treadmill training on slow speed along with physiotherapy. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to walk on treadmill for 20 min
- Cognitively able to perform required task
- Hoehn and yarn disease stage between I to III.
Key exclusion criteria (8 listed)
- Gait impairment
- Cardiac impairment
- Dementia
- History of fall
- Severe Freezing episodes
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 |
|---|---|---|
| speed dependent treadmill training on moderate speedExperimental group will receive 14 session of speed dependent treadmill training on moderate speed (3 to 6) for 25 minutes along with strengthening, stretching and range of motion exercises. | Device | speed dependent treadmill training on moderate speed |
| speed dependent treadmill training on slow speedControl group will receive 14 session of speed dependent treadmill training on slow speed (1 to 2) for 25 min along with physiotherapy. | Device | speed dependent treadmill training on slow speed |
Primary outcome
Unified Parkinson disease rating scale (UPDRS-III)
Time frame: 1 day
UPDRS-III is a "Gold standered" for Parkinson disease. It completely access the body function, activities and participation of Parkinson's patient. It consist of 6 session. We will only use Scale's motor component, which consist of 14 item. Each sign and symptom is rated on a 5-point scale (ranging from 0 to 4) higher score represent severe impairment. Highest point represent total or maximal disability.
1 secondary outcome
dual task gait speed test
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 33611557Baek CY, Chang WN, Park BY, Lee KB, Kang KY, Choi MR. Effects of Dual-Task Gait Treadmill Training on Gait Ability, Dual-Task Interference, and Fall Efficacy in People With Stroke: A Randomized Controlled Trial. Phys Ther. 2021 Jun 1;101(6):pzab067. doi: 10.1093/ptj/pzab067.
- Background: PubMed 35697942Gassner H, Trutt E, Seifferth S, Friedrich J, Zucker D, Salhani Z, Adler W, Winkler J, Jost WH. Treadmill training and physiotherapy similarly improve dual task gait performance: a randomized-controlled trial in Parkinson's disease. J Neural Transm (Vienna). 2022 Sep;129(9):1189-1200. doi: 10.1007/s00702-022-02514-4. Epub 2022 Jun 13.
- Background: PubMed 17846069Cakit BD, Saracoglu M, Genc H, Erdem HR, Inan L. The effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease. Clin Rehabil. 2007 Aug;21(8):698-705. doi: 10.1177/0269215507077269.
- Background: PubMed 25703649Verstraeten A, Theuns J, Van Broeckhoven C. Progress in unraveling the genetic etiology of Parkinson disease in a genomic era. Trends Genet. 2015 Mar;31(3):140-9. doi: 10.1016/j.tig.2015.01.004. Epub 2015 Feb 20.
- Background: PubMed 18816800Rochester L, Nieuwboer A, Baker K, Hetherington V, Willems AM, Kwakkel G, Van Wegen E, Lim I, Jones D. Walking speed during single and dual tasks in Parkinson's disease: which characteristics are important? Mov Disord. 2008 Dec 15;23(16):2312-8. doi: 10.1002/mds.22219.
- Background: PubMed 21279632Plotnik M, Giladi N, Dagan Y, Hausdorff JM. Postural instability and fall risk in Parkinson's disease: impaired dual tasking, pacing, and bilateral coordination of gait during the "ON" medication state. Exp Brain Res. 2011 May;210(3-4):529-38. doi: 10.1007/s00221-011-2551-0. Epub 2011 Jan 30.
- Background: PubMed 33177223Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.
- Background: PubMed 23129815Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Aug;27(8):675-80. doi: 10.1177/0269215512464702. Epub 2012 Nov 5.
- Background: PubMed 26297797Mehrholz J, Kugler J, Storch A, Pohl M, Elsner B, Hirsch K. Treadmill training for patients with Parkinson's disease. Cochrane Database Syst Rev. 2015 Aug 22;(8):CD007830. doi: 10.1002/14651858.CD007830.pub3.
- Background: PubMed 35270516Bishnoi A, Lee R, Hu Y, Mahoney JR, Hernandez ME. Effect of Treadmill Training Interventions on Spatiotemporal Gait Parameters in Older Adults with Neurological Disorders: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2022 Feb 28;19(5):2824. doi: 10.3390/ijerph19052824.
- Background: PubMed 28815562Mehrholz J, Thomas S, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2017 Aug 17;8(8):CD002840. doi: 10.1002/14651858.CD002840.pub4.
- Background: PubMed 30213258Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.
- 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.
Wajiha Shahid, Phd 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 speed dependent treadmill training on moderate speed and speed dependent treadmill training on slow speed in people with Parkinson Disease, 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 8 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 15 Jun 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 Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson disease rating scale (UPDRS-III) (time frame: 1 day). 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 NCT05903755, which also lists 15 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 15 Jun 2023.