Clinical trial NCT01439451: Effect of Perturbation Training on Balance Control in Elderly Persons
Official title: Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Balance control
Aging
Balance reactions
Perturbation
above seventy years old
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.

Detailed description: A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.

Eligibility criteria: Inclusion Criteria:

* Be 70 years or older, male or female
* Be an independent ambulator (not cane or walker) and provide medical waiver from MD.

Exclusion Criteria:

* Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
* Moderate-severe dementia (Mini-Mental Score \< 24).
* Serious visual impairment
* Severe peripheral or compression/entrapment neuropathies.
* Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
* Cancer, metastatic or under active treatment.

Primary outcomes:
measure: voluntary and compensatory step execution times in miliseconds
timeFrame: change from baseline to 3 months later
Secondary outcomes:
measure: postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres
timeFrame: Time 1: pre test' and 3 months later time 2: post testing procedure
Other outcomes:
Locations:
city: Beer-sheva
country: Israel
facility: Ben-Gurion University of the Negev
city: Beer-Sheva
country: Israel
facility: Beit Yona
Study officials:
affiliation: Barzilai Medical Center
name: Ronen Debi, MD
role: STUDY_CHAIR
References:
citation: Batcir S, Shani G, Shapiro A, Alexander N, Melzer I. The kinematics and strategies of recovery steps during lateral losses of balance in standing at different perturbation magnitudes in older adults with varying history of falls. BMC Geriatr. 2020 Jul 20;20(1):249. doi: 10.1186/s12877-020-01650-4.
citation: Nachmani H, Shani G, Shapiro A, Melzer I. Characteristics of First Recovery Step Response following Unexpected Loss of Balance during Walking: A Dynamic Approach. Gerontology. 2020;66(4):362-370. doi: 10.1159/000505649. Epub 2020 Feb 18.
citation: Kurz I, Gimmon Y, Shapiro A, Debi R, Snir Y, Melzer I. Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial. BMC Geriatr. 2016 Mar 4;16:58. doi: 10.1186/s12877-016-0223-4.