Parkinson Clinical Trial
Official title:
V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
The proposed randomized controlled trial will evaluate the effects of treadmill training
augmented with virtual reality on fall risk.
300 older adults with a history of falls will be recruited to participate in this study.
This will include older adults (n=100), patients with mild cognitive impairment (MCI)
(n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly
assigned to the intervention group (treadmill training with virtual reality) or to the
active-control group (treadmill training without virtual reality). Each person will
participate in a training program set in an outpatient setting 3 times per week for 6 weeks.
Assessments will take place before, after, and 1 month and 6 months after the completion of
the training.
A prospective, single blinded, parallel group, randomized controlled trial with 6 month
follow-up will be employed to investigate the effects of treadmill training augmented with
virtual reality on fall risk. The study will include 300 older participants who have
experienced two or more falls in the previous 6 months. Participants will be randomized to
either the intervention or control group. The intervention group will receive 18 sessions of
Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will
receive 18 training sessions of treadmill training alone (TT) without the VR simulation All
interventions will be delivered by therapists trained in the standard protocols. All
subjects will be trained 3 times a week for 6 weeks, each session will last approximately 45
minutes.Training progression will be based on increasing both motor and cognitive
challenges, individualized to the participant's level of performance.
Primary outcome measures:
The primary outcome measure of the study is fall rate for 6 months post intervention.
Secondary outcome measures will include gait speed and gait variability under usual and dual
task conditions and while negotiating physical obstacles will be measured. Endurance will be
assessed using the 2 Minute Walk Test and mobility will be assessed using the Four Square
Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance
Evaluation Systems Test (mini-BESTest). Community ambulation will be assessed using a
tri-axial accelerometer ('Axivity' Ltd.)which will be worn by the participants for 7 days.
Cognitive function will be assessed using a computerized neuropsychological test battery
(Mindstreams, 'NeuroTrax' Corp., NJ) as well as standardized neuropsychological tests
(Montreal Cognitive Assessment,The Trail Making Test; Verbal Fluency). Quality of life will
be evaluated using the SF-36 Health Survey
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06037590 -
A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA®
|
Phase 1 | |
Recruiting |
NCT01537224 -
Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information
|
N/A | |
Withdrawn |
NCT04011449 -
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
|
N/A | |
Completed |
NCT02539446 -
Suprapostural Attention Focus and Postural Difficulty on H-reflex and Brain Activity: Aging and Parkinson's Disease
|
N/A | |
Completed |
NCT00358189 -
Effects of Deep Brain Stimulation for the Treatment of Parkinson's Disease
|
N/A | |
Active, not recruiting |
NCT04606979 -
tDCS of the Primary Motor Cortex to Improve Implicit Motor Sequence Learning in Parkinson's Disease
|
N/A | |
Completed |
NCT05119803 -
The Relationship of Spine Posture and Mobility With Upper Extremity Functions in Parkinson's Patients
|
||
Recruiting |
NCT06154772 -
Quality of Life, Anxiety and Fatigue Level of Parkison's Patients With Color Therapy
|
N/A | |
Not yet recruiting |
NCT02249715 -
Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease
|
N/A | |
Completed |
NCT03232996 -
Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.
|
N/A | |
Enrolling by invitation |
NCT04566341 -
Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
|
||
Active, not recruiting |
NCT04978597 -
Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)
|
Phase 3 | |
Recruiting |
NCT06116084 -
Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine
|
N/A | |
Recruiting |
NCT05830396 -
GRoningen Early-PD Ambroxol Treatment
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05379062 -
Choral Singing for Patients With Parkinson's
|
N/A | |
Completed |
NCT02071823 -
Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
|
Phase 1 | |
Recruiting |
NCT03558568 -
The Effect of Deep Brain Stimulation on Facial Expressions.
|
N/A | |
Enrolling by invitation |
NCT05596201 -
Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
|
||
Recruiting |
NCT04181918 -
Action Observation Treatment in Parkinson's Patients
|
N/A | |
Completed |
NCT02305277 -
Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
|
Phase 1 |