NCT05903755

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 6, 2023

Last Update Submit

June 13, 2023

Conditions

Parkinson Disease

Keywords

Treadmill trainingDual-task performanceParkinson diseasePhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • dual task gait speed test

    1 day

Study Arms (2)

speed dependent treadmill training on moderate speed

EXPERIMENTAL

speed dependent treadmill training on moderate speed along with strengthening, stretching and range of motion exercises.

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.

Device: speed dependent treadmill training on slow speed

Interventions

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 moderate speed
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.

speed dependent treadmill training on slow speed

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to walk on treadmill for 20 min
  • Cognitively able to perform required task
  • Hoehn and yarn disease stage between I to III.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (15)

  • 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.

    PMID: 33611557BACKGROUND

  • 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.

    PMID: 35697942BACKGROUND

  • 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.

    PMID: 17846069BACKGROUND

  • 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.

    PMID: 25703649BACKGROUND

  • 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.

    PMID: 18816800BACKGROUND

  • 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.

    PMID: 21279632BACKGROUND

  • 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.

    PMID: 33177223BACKGROUND

  • 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.

    PMID: 23129815BACKGROUND

  • 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.

    PMID: 26297797BACKGROUND

  • 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.

    PMID: 35270516BACKGROUND

  • 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.

    PMID: 28815562BACKGROUND

  • 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.

    PMID: 30213258BACKGROUND

  • 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.

    PMID: 14669180BACKGROUND

  • 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.

    PMID: 36079092BACKGROUND

  • 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.

    PMID: 36239376BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Wajiha Shahid, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

January 2, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)