Clinical trial NCT01732653: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Adults
Parkinson
Mild Cognitive Disorder
Keywords: virtual reality,
falls,
elderly,
Parkinson's disease,
MCI
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Newcastle University
name: University Medical Center Nijmegen
name: Universita degli Studi di Genova
name: KU Leuven
First posted: 2012-11-26
Enrollment: 302
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 2 or more falls within 6 months prior to the beginning of the study
* Aged 60-85 years
* Able to walk for 5 minutes unassisted
* Adequate hearing and vision capabilities.
* Stable medication for the past 1 month and anticipated over a period of 6 months

Exclusion Criteria:

* Psychiatric co-morbidity
* Clinical diagnosis of dementia or other severe cognitive impairment (MMSE\<24)
* History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
* Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
* Unstable medical condition in the past 6 months
* Unable to comply with the training
* Interfering therapy

Primary outcomes:
measure: Falls rate
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Gait
timeFrame: 6 months post intervention
measure: Cognitive function
timeFrame: 6 months post intervention
measure: Balance and mobility
timeFrame: 6 months post intervention
measure: Quality of life
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Rehabilitation Sciences, Katholieke Universiteit Leuven
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Genova
country: Italy
facility: Department of Neurosciences Universita Degli Studi Di Genova, Italy
city: Nijmegen
country: Netherlands
facility: Department of Geriatric Medicine and Neurology, Radboud University Nijmegen Medical Center The Netherlands
city: Newcastle
country: United Kingdom
facility: Institute for Aging and Health, University of Newcastle, UK
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Jeffrey M Hausdorff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maidan I, Hacham R, Galperin I, Giladi N, Holtzer R, Hausdorff JM, Mirelman A. Neural Variability in the Prefrontal Cortex as a Reflection of Neural Flexibility and Stability in Patients With Parkinson Disease. Neurology. 2022 Feb 22;98(8):e839-e847. doi: 10.1212/WNL.0000000000013217. Epub 2021 Dec 14.
citation: Droby A, Maidan I, Jacob Y, Giladi N, Hausdorff JM, Mirelman A. Distinct Effects of Motor Training on Resting-State Functional Networks of the Brain in Parkinson's Disease. Neurorehabil Neural Repair. 2020 Sep;34(9):795-803. doi: 10.1177/1545968320940985. Epub 2020 Jul 18.
citation: Mirelman A, Rochester L, Maidan I, Del Din S, Alcock L, Nieuwhof F, Rikkert MO, Bloem BR, Pelosin E, Avanzino L, Abbruzzese G, Dockx K, Bekkers E, Giladi N, Nieuwboer A, Hausdorff JM. Addition of a non-immersive virtual reality component to treadmill training to reduce fall risk in older adults (V-TIME): a randomised controlled trial. Lancet. 2016 Sep 17;388(10050):1170-82. doi: 10.1016/S0140-6736(16)31325-3. Epub 2016 Aug 11.
citation: Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.