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- Klinische proef NCT05218187
Robotische looprevalidatie bij de ziekte van Parkinson
The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes.
Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability.
Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.
Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, function, and quality of life
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Individuals diagnosed with Parkinson's disease (PD) often suffer from difficulties with gait initiation, maintaining a consistent kinematic gait pattern, and transitions between gait environments. Focused gait training that provides an environment that can emphasize motor control improvement in these deficits would be ideal for building a rehabilitative foundation for gait recovery for individuals with PD.
One approach that has been used to maintain and restore function in other neurological populations with severe disability is gait rehabilitation using treadmill training. This approach allows for specific and repetitive practice of walking movement and can involve therapist or electromechanical assistance. There is preliminary evidence from two small, uncontrolled studies supporting the benefits of therapist-assisted treadmill training on walking, balance, fatigue, spasticity, muscle strength, and quality of life in patients with PPMS and SPMS. Nevertheless, therapist-assisted gait training can require up to three trainers per patient making it burdensome and inefficient in the clinical setting. The intensity of manual treadmill training is low (i.e., <1.5 METs) based in part on the physical capacity and fitness level of the trainers, yet physiological adaptations for optimizing outcomes require moderate or vigorous intensity exercise.
Robotic-assisted gait training (RAGT) addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology AG: Olten, Switzerland) is a novel end-effector robotic gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback. Gait training using the G-EO System has been applied in patients with stroke, Multiple Sclerosis (MS), and cerebral palsy (CP). These studies have established safety and feasibility, and preliminary evidence for benefits on mobility and function. For example, two studies involving 4 weeks of G-EO training with conventional physical therapy in non-ambulatory subacute stroke patients reported improved gait, stair climbing ability, leg strength, and activities of daily living (ADL) compared to physical therapy alone. There is limited RAGT studies evaluating the impact of this type of training for individuals with PD. The potential focus on improved gait kinematics may be of particular benefit for PD patients who often struggle with maintain step length and initiation.
The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as an effective rehabilitation tool for restoring and maintaining function in Parkinson's disease. This approach represents an opportunity for improving current clinical practices for patients with Parkinson's disease. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach.
The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes.
Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability. Enrolled participants will be randomized to either conventional physical therapy (CPT) or CPT with G-EO training. Participants will complete baseline assessments on Day 1 and then be scheduled for the intervention phase of the study. Regardless of group allocation, each participant will receive 12 total visits scheduled ideally for twice a week for 6 weeks. Within one week of completing the 12th physical therapy visit, participants will repeat the outcome assessments (post-intervention timepoint). Participants will then be asked to return 30 days later for a final outcome assessment (one month follow-up timepoint).
Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.
Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, function, and quality of life.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- IU Health Neurorehabilitation and Robotics
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age > 18years
- Confirmed diagnosis of Parkinson's Disease
- Hoehn and Yahr stage 1 to 3
- Stable course of disease-modifying therapy over the past 3 months
- Mini Mental State Examination > 24
- Physician approval for exercise
- Stable deep brain stimulation setting for the past year
- Demonstrate a need for functional rehabilitation
Exclusion Criteria:
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• Severe dyskinesia or severe on-off phenomenon
- Unstable medication regiment
- Any co-morbidity that will interfere with walking
- Conventional physical therapy or G-EO training within the past 6 months
- Height <1m or >2m
- Body weight >150 kg
- Contraindications to G-EO gait training (e.g., bone instability)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Conventional Physical Therapy (CPT) Group
CPT sessions will involve a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training exercises, and balance training. Gait training will be provided using traditional over-ground walking. Additional strategies for home exercises, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Training will be administered 2 times per week for 40-60 minutes for six weeks. |
Therapists will use traditional methods of neurological rehabilitation for improved gait and balance. These approaches will include stretching, strengthening, therapeutic exercises, balance training, and over-ground walking |
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Experimenteel: Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO)
CPT-GEO sessions will involve a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training exercises, and balance training. Gait training will be administered using end-effector gait training protocols (G-EO trainer). Training will be administered 2 times per week for 40-60 minutes for six weeks. |
Therapists will use traditional methods of neurological rehabilitation for improved gait and balance. These approaches will include stretching, strengthening, therapeutic exercises, balance training, and over-ground walking The G-EO Gait Trainer uses distal fixation to promote a gait recovery by facilitating a controlled walking environment that includes an over-ground pattern and stair climbing. In addition, the device provides body position control to enable the patient to concentrate on the cyclical motion of walking without the fear of falling. Physical therapists can control different parameters of the gait cycle through computerized adjustments and the training setting can be manipulated to engage patients in active participation. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Comfortable Walking Speed (CWS)
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Participants will be asked to walk over a 14-foot pressure mat that will capture their comfortable walking speed. Patients will be instructed to walk at their normal comfortable speed. Walking will begin 5 feet prior to the mat so that each individual walks across the mat at a consistent speed. Participants will pass over the mat 2 times and an average speed will be calculated. It will take 5 minutes to complete this test and will be performed first. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Fast Walking Speed (FWS)
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Participants will be asked to walk over a 14-foot pressure mat that will capture their fast walking speed. Patients will be instructed to walk at their fastest speed while maintaining safe, accurate gait. Walking will begin 5 feet prior to the mat so that each individual walks across the mat at a consistent speed. Participants will pass over the mat 2 times and an average speed will be calculated. It will take 5 minutes to complete this test and will be performed second. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Six Minute Walk Test (6MWT)
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Participants will be asked to walk for 6 minutes along a 30m track that is a flat surface and obstacle free. Subjects may stop and rest as often as needed. Researchers will record the distance traveled during the six minute time period. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Six Minute Walk Test Walking Speed (6MWT)
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Average walking speed during the 6-Minute Walk Test was measured in meters per second (m/s). Change from baseline was calculated at post-intervention and one-month follow-up. Positive change scores indicate increased average walking speed and improved performance. This is not a scale score. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Five Times Sit to Stand Test
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The test will quantify functional lower extremity strength. It provides insight into the coordination of functional strength for the accomplishment of transitioning from one posture to another. The participant is asked to safely rise from sitting in a chair to standing and then sit back down five times in a row without using their hands. This test will take about 5 minutes to administer. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Activities-Specific Balance Confidence Scale (ABC)
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Activities-specific Balance Confidence (ABC) Scale assesses self-reported confidence in maintaining balance while performing activities of daily living. The scale contains 16 items, with each item rated from 0 (no confidence) to 100 (complete confidence). The total ABC score is calculated as the average of the 16 item scores and ranges from 0 to 100. Higher scores indicate greater balance confidence and a better outcome; lower scores indicate less balance confidence and a worse outcome. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Mini-Balance Evaluation Systems Test (MiniBESTest) - Anticipatory Subscale
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Mini-Balance Evaluation Systems Test (MiniBESTest) is a performance-based measure of dynamic balance. The Anticipatory subscale assesses anticipatory postural adjustments during functional movement. Item scores are summed to produce a subscale score ranging from 0 to 6 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Mini-Balance Evaluation Systems Test (MiniBESTest) - Reactive Postural Control Subscale
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Mini-Balance Evaluation Systems Test (MiniBESTest) is a performance-based measure of dynamic balance. The Reactive Postural Control subscale assesses the ability to recover balance following an external perturbation; examining the effectiveness of compensatory stepping response. Item scores are summed to produce a subscale score ranging from 0 to 6 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Mini-Balance Evaluation Systems Test (MiniBESTest) - Sensory Orientation Subscale
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Mini-Balance Evaluation Systems Test (MiniBESTest) evaluates an individual's ability to maintain postural stability when sensory information is altered or conflicting. It assesses how effectively a person uses visual, vestibular, and somatosensory inputs to maintain balance under increasingly challenging conditions. Item scores are summed to produce a subscale score ranging from 0 to 6 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Mini-Balance Evaluation Systems Test (MiniBESTest) - Dynamic Gait Subscale
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Mini-Balance Evaluation Systems Test (MiniBESTest) is a performance-based measure of dynamic balance. It evaluates an individual's ability to maintain balance while walking under increasingly complex and functionally relevant conditions. It assesses the capacity to adapt gait when confronted with environmental demands, dual-tasking, changes in speed, head movements, obstacle negotiation, and turning. Item scores are summed to produce a subscale score ranging from 0 to 10 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Score
Tijdsspanne: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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The Parkinson's Disease Questionnaire-39 (PDQ-39) is a 39-item, disease-specific questionnaire assessing health-related quality of life in individuals with Parkinson's disease. It includes eight domains: Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort. Each item is scored from 0 to 4, with higher scores indicating greater difficulty. Individual domain scores are calculated by summing item responses, dividing by the maximum possible domain score, and multiplying by 100. Each domain ranges from 0 to 100. The PDQ-39 Summary Index is calculated as the unweighted mean of the eight domain scores and ranges from 0 to 100. Lower scores indicate better health-related quality of life, while higher scores indicate worse health-related quality of life. |
Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit
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Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Synucleïnopathieën
- Neurologische manifestaties
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Neurodegeneratieve ziekten
- Bewegingsstoornissen
- Parkinson-stoornissen
- Basale ganglia-ziekten
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Ziekte van Parkinson
- Loopstoornissen, neurologisch
Andere studie-ID-nummers
- 11829
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
It is not determined at this time.
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