NCT01732653

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.4 years

First QC Date

November 5, 2012

Last Update Submit

April 17, 2016

Conditions

Elderly AdultsParkinsonMild Cognitive Disorder

Keywords

virtual reality,falls,elderly,Parkinson's disease,MCI

Outcome Measures

Primary Outcomes (1)

  • Falls rate

    The primary outcome measure of the study is fall rate. Participants will keep a falls calendar for 6 months post intervention. Each time the participant falls he/she will tick the date on the calendar. These calendars will be returned to the researchers once a month in a pre-addressed envelope.

    6 months post intervention

Secondary Outcomes (4)

  • Gait

    6 months post intervention

  • Cognitive function

    6 months post intervention

  • Balance and mobility

    6 months post intervention

  • Quality of life

    6 months post intervention

Study Arms (2)

TT+VR

EXPERIMENTAL

The training will consist of walking on the treadmill while negotiating obstacles in a virtual reality simulation.Training will be provided3 times a week for a duration of 6 weeks (total of 18 sessions).

Other: TT+VR

TT alone

ACTIVE COMPARATOR

The training will consist of walking on the treadmill 3 times a week for a duration of 6 weeks (total of 18 sessions).

Other: TT alone

Interventions

TT+VROTHER

subjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol.

Also known as: training on a treadmill with virtual reality
TT+VR
TT aloneOTHER

The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.

Also known as: treadmill training
TT alone

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Rehabilitation Sciences, Katholieke Universiteit Leuven

Leuven, Belgium

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Department of Neurosciences Universita Degli Studi Di Genova, Italy

Genova, Italy

Location

Department of Geriatric Medicine and Neurology, Radboud University Nijmegen Medical Center The Netherlands

Nijmegen, Netherlands

Location

Institute for Aging and Health, University of Newcastle, UK

Newcastle, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 34906983DERIVED

  • 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.

    PMID: 32684069DERIVED

  • 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.

    PMID: 27524393DERIVED

  • 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.

    PMID: 23388087DERIVED

MeSH Terms

Conditions

Neurocognitive DisordersParkinson Disease

Condition Hierarchy (Ancestors)

Mental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jeffrey M Hausdorff, PhD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 26, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2015

Study Completion

December 1, 2015

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

IT(1)IL(1)BE(1)NL(1)GB(1)