NCT00187317

Brief Summary

This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 2, 2010

Status Verified

April 1, 2010

Enrollment Period

1.3 years

First QC Date

September 9, 2005

Last Update Submit

April 1, 2010

Conditions

Accidental Falls

Keywords

ExerciseRehabilitationPostural BalanceAccidental FallsGeriatrics

Outcome Measures

Primary Outcomes (1)

  • Ability to recover balance by stepping and grasping

    Before and after 6-week intervention

Secondary Outcomes (1)

  • Fall frequency; clinical measures related to balance and fall risk (e.g. FallScreen, Community Balance and Mobility Scale, balance confidence)

    One year post-intervention

Study Arms (2)

PERT

EXPERIMENTAL

Perturbation-based balance training.

Behavioral: Balance training (exercise)

CON

PLACEBO COMPARATOR

Flexibility and relaxation training.

Other: Flexibility and relaxation exercise

Interventions

Balance training (exercise)BEHAVIORAL

Perturbation-based balance training. 30-minute sessions three times per week for six weeks.

PERT
Flexibility and relaxation exerciseOTHER

30-minute sessions, three times per week for six weeks.

CON

Eligibility Criteria

Age64 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community dwelling
  • History of falls (at least 1 fall in the past 12 months) or poor balance
  • Functional mobility (no dependence on mobility aids)

You may not qualify if:

  • Neurological or musculoskeletal disorder
  • Cognitive disorder (e.g. dementia)
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Studies in Aging, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (8)

  • Maki BE, McIlroy WE, Perry SD. Influence of lateral destabilization on compensatory stepping responses. J Biomech. 1996 Mar;29(3):343-53. doi: 10.1016/0021-9290(95)00053-4.

    PMID: 8850640BACKGROUND

  • Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.

    PMID: 7715058BACKGROUND

  • Rogers MW, Johnson ME, Martinez KM, Mille ML, Hedman LD. Step training improves the speed of voluntary step initiation in aging. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):46-51. doi: 10.1093/gerona/58.1.m46.

    PMID: 12560410BACKGROUND

  • McIlroy WE, Maki BE. Age-related changes in compensatory stepping in response to unpredictable perturbations. J Gerontol A Biol Sci Med Sci. 1996 Nov;51(6):M289-96. doi: 10.1093/gerona/51a.6.m289.

    PMID: 8914501BACKGROUND

  • Maki BE, McIlroy WE. Change-in-support balance reactions in older persons: an emerging research area of clinical importance. Neurol Clin. 2005 Aug;23(3):751-83, vi-vii. doi: 10.1016/j.ncl.2005.01.002. No abstract available.

    PMID: 16026675BACKGROUND

  • Maki BE, Cheng KC, Mansfield A, Scovil CY, Perry SD, Peters AL, McKay S, Lee T, Marquis A, Corbeil P, Fernie GR, Liu B, McIlroy WE. Preventing falls in older adults: new interventions to promote more effective change-in-support balance reactions. J Electromyogr Kinesiol. 2008 Apr;18(2):243-54. doi: 10.1016/j.jelekin.2007.06.005. Epub 2007 Sep 4.

    PMID: 17766146BACKGROUND

  • Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.

    PMID: 17540020RESULT

  • Mansfield A, Peters AL, Liu BA, Maki BE. Effect of a perturbation-based balance training program on compensatory stepping and grasping reactions in older adults: a randomized controlled trial. Phys Ther. 2010 Apr;90(4):476-91. doi: 10.2522/ptj.20090070. Epub 2010 Feb 18.

    PMID: 20167644RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

ExercisePliability

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMechanical PhenomenaPhysical Phenomena

Study Officials

  • Brian Maki, PhD, PEng

    Sunnybrook & Women's College Health Sciences Centre; University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

November 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2008

Last Updated

April 2, 2010

Record last verified: 2010-04

Locations

CA(1)