- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05903755
the Effect of Speed Dependent Treadmill Training on Dual Task Performance in Patient With Parkinson's Disease.
To Understand the Effect of Speed Dependent Treadmill Training on Dual Task Performance in Patient With Parkinson's Disease.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- General Hospital
-
Contact:
- Wajiha Shahid, PhD
- Phone Number: 03214885079
- Email: wajiha.shahid@riphah.edu.pk
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Principal Investigator:
- Rahma A. Hameed, MS-NMPT
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Sub-Investigator:
- wajiha shahid, Phd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to walk on treadmill for 20 min
- Cognitively able to perform required task
- Hoehn and yarn disease stage between I to III.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: speed dependent treadmill training on moderate speed
speed dependent treadmill training on moderate speed along with strengthening, stretching and range of motion exercises.
|
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.
|
|
Active Comparator: speed dependent treadmill training on slow speed
Speed dependent treadmill training on slow speed along with physiotherapy.
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Control group will receive 14 session of speed dependent treadmill training on slow speed (1 to 2) for 25 min along with physiotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dual task gait speed test
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wajiha Shahid, PhD, Riphah International University
Publications and helpful links
General Publications
- Mehrholz 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.
- Plotnik 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.
- Cakit 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.
- Dai 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.
- Cho 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.
- Aprile 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.
- 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. Erratum In: Phys Ther. 2022 Jul 4;102(7):
- Gassner 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.
- Verstraeten 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.
- Rochester 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.
- Mehrholz 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.
- Bishnoi 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.
- Alghadir 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.
- Pohl 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.
- Hulzinga 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- REC/RCR &AHS/23/0223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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