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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05903755
Other study ID # REC/RCR &AHS/23/0223
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2023
Est. completion date October 2023

Study information

Verified date June 2023
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
speed dependent treadmill training on moderate speed
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 speed
Control group will receive 14 session of speed dependent treadmill training on slow speed (1 to 2) for 25 min along with physiotherapy.

Locations

Country Name City State
Pakistan General Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

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. — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 1 day
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