Parkinson Disease Clinical Trial
— GAITimageryOfficial title:
Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease
NCT number | NCT04788693 |
Other study ID # | 1557673 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 4, 2023 |
Est. completion date | July 2024 |
This study aims to determine whether gait training combined with motor imagery exercises has a superior effect on the biomechanics of gait, functionality in activities of daily living, motor capacity, and the perception of the quality of life in people. people with Parkinson's disease, than gait training without motor imagery. To do this, a six-week training program will be carried out, where walking exercises and motor imaging will be performed twice a week in the experimental group, while only walking exercises will be performed in the control group. Motor imagery exercises consist of performing a mental exercise by which an individual rehearses or simulates a given action. Our hypothesis is that participants who perform motor imagery exercises have better results than participants who train without imagery exercises.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being diagnosed with PD according to the United Kingdom Parkinson's Disease Society Brain Bank diagnostic scale, ratified through a report made by the neurologist - To present a score from I to III on the Hoehn and Yahr scale, which implies not requiring support or help from a third person to walk - To not present alteration in their cognitive state, determined by a score higher than 25 in the Mini-Mental State Examination - To have stable medication from the month prior to the start of the study until the complete conclusion of the study. Exclusion Criteria: - To present another pathology or neurological alteration different from Parkinson's disease - To present an acute clinical presentation of musculoskeletal disease or disorder that limits mobility; - To report pain greater than 3 points on the Visual Analogue Scale - To suffer blindness, deafness and / or any other visual / auditory alteration or pathology that may influence the ability to understand instructions and carry them out - To present uncontrolled chronic diseases - To suffer balance impairments due to other diseases. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia | Asociación Parkinson Valencia |
Spain,
Bek J, Gowen E, Vogt S, Crawford TJ, Poliakoff E. Combined action observation and motor imagery influences hand movement amplitude in Parkinson's disease. Parkinsonism Relat Disord. 2019 Apr;61:126-131. doi: 10.1016/j.parkreldis.2018.11.001. Epub 2018 Nov 9. No abstract available. — View Citation
Bek J, Webb J, Gowen E, Vogt S, Crawford TJ, Sullivan MS, Poliakoff E. Patients' Views on a Combined Action Observation and Motor Imagery Intervention for Parkinson's Disease. Parkinsons Dis. 2016;2016:7047910. doi: 10.1155/2016/7047910. Epub 2016 Sep 29. — View Citation
Braun S, Beurskens A, Kleynen M, Schols J, Wade D. Rehabilitation with mental practice has similar effects on mobility as rehabilitation with relaxation in people with Parkinson's disease: a multicentre randomised trial. J Physiother. 2011;57(1):27-34. doi: 10.1016/S1836-9553(11)70004-2. — View Citation
Santiago LM, de Oliveira DA, de Macedo Ferreira LG, de Brito Pinto HY, Spaniol AP, de Lucena Trigueiro LC, Ribeiro TS, de Sousa AV, Piemonte ME, Lindquist AR. Immediate effects of adding mental practice to physical practice on the gait of individuals with — View Citation
Scarpina F, Magnani FG, Tagini S, Priano L, Mauro A, Sedda A. Mental representation of the body in action in Parkinson's disease. Exp Brain Res. 2019 Oct;237(10):2505-2521. doi: 10.1007/s00221-019-05608-w. Epub 2019 Jul 20. — View Citation
Subramanian L, Morris MB, Brosnan M, Turner DL, Morris HR, Linden DE. Functional Magnetic Resonance Imaging Neurofeedback-guided Motor Imagery Training and Motor Training for Parkinson's Disease: Randomized Trial. Front Behav Neurosci. 2016 Jun 8;10:111. doi: 10.3389/fnbeh.2016.00111. eCollection 2016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Gait velocity at 6 weeks | Distance traveled by the body per unit of time, in the direction considered. It is expressed in meters per second (m / s). | 6 weeks | |
Secondary | Stride length | Distance measured between two consecutive supports points of the same foot; the heel strike is the reference used. It is expressed in meters (m). | 6 weeks | |
Secondary | Speed variability | Variability of walking speed estimated from the repetitions performed at each measurement time. | 6 weeks | |
Secondary | Support/ Stance time (s) | Time elapsed while the support or stance phase of the gait cycle is developed. It is expressed as a percentage of the total walking cycle. | 6 weeks | |
Secondary | Cadence (steps/min) | Number of steps executed in a time interval, its most commonly adopted unit being the step per minute. | 6 weeks | |
Secondary | Swing time | Time elapsed while the swing phase develops. It is expressed as a percentage according to the entire walking cycle. | 6 weeks | |
Secondary | Range of motion of lower limb joint (°) | Kinematic outcome that represents the range of motion in the sagittal plane of the hip, knee, and ankle joints performed during the gait cycle. These parameters will be specified for each limb (right and left). | 6 weeks | |
Secondary | Maximum ankle dorsiflexion during swing (°) | Kinematic outcome; Maximum ankle dorsiflexion angle reached during the swing phase, expressed in degrees. | 6 weeks | |
Secondary | Maximum knee flexion during swing (°) | Kinematic outcome; Maximum knee flexion angle reached during the swing phase, expressed in degrees. | 6 weeks | |
Secondary | Maximum hip extension during stance (°) | Kinematic outcome; Maximum hip extension angle reached during the stance phase, expressed in degrees. | 6 weeks | |
Secondary | Maximum hip flexion during swing (°) | Kinematic outcome; Maximum hip flexion angle reached during the swing phase, expressed in degrees. | 6 weeks | |
Secondary | Weight-acceptance Ground Reaction Force (Newton, N; Weight%) | Kinetic outcome; First force peak of vertical vector of the ground reaction forces during the stance phase of the gait cycle, which corresponds to the maximum reception of weight on the foot that initiates the gait cycle. | 6 weeks | |
Secondary | Midstance Ground Reaction Force (Newton, N; Weight%) | Kinetic outcome; Lowest force point of the valley located between both maximum force peaks of the vertical vector of the ground reaction forces, which corresponds to the swing of the opposite leg during the gait cycle. | 6 weeks | |
Secondary | Push-off Ground Reaction Force (Newton, N; Weight%) | Kinetic outcome; Second and last force peak of the vertical vector of the ground reaction forces during the stance phase of the gait cycle, which corresponds to the beginning of takeoff of the foot during the last part of the stance phase. | 6 weeks | |
Secondary | Breaking Ground Reaction Force (Newton, N; Weight%) | Kinetic outcome; First maximum force peak of the antero-posterior vector of the ground reaction forces during the gait cycle that corresponds to the braking of the foot on the ground. | 6 weeks | |
Secondary | Propulsion Ground Reaction Force (Newton, N; Weight%) | Kinetic outcome; Second maximum force peak of the antero-posterior vector of the ground reaction forces during the gait cycle that corresponds to the propulsion of the foot on the ground at the end of the stance phase. | 6 weeks | |
Secondary | Quality of Life referred | Schwab & England scale score; Parkinson's Disease Questionnaire-39 score | 6 weeks | |
Secondary | Freezing of gait | Freezing of gait Questionnaire score | 6 weeks | |
Secondary | Gait qualitative performance | Tinetti mobility test - Gait section score; Dynamic Parkinson Gait Scale score | 6 weeks | |
Secondary | Balance qualitative performance | Tinetti mobility test - Balance section score | 6 weeks | |
Secondary | Mobility | Timed-up and go test (s) | 6 weeks |
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