Self Mobility Improvement in the Elderly by Counteracting Falls (SMILING)

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00877721
First received: April 7, 2009
Last updated: September 19, 2010
Last verified: April 2009
  Purpose

Experimental design overview:

The proposed project is a prospective experimental study design. Independent old adults (age 65 years old and older) who suffer from minor balance problems willing to participate in the study will be tested with well-established measuring techniques of balance and gait before and 4 weeks after balance training program using the "Self Mobility Improvement in the Elderly by Counteracting Falls" system (SMILING system). The study design is randomized clinical trial (RCT), cross over, single blinded study design where 30 subjects will randomly be allocated into experimental or control groups that will switch groups after 4 weeks of intervention.

Random sequence generation will be performed by a staff member who will not interact with subjects during the balance-testing sessions. Subjects will be informed that they are to be randomly assigned to one of the two groups, both receiving gait training program.

The staff member who administers the training programs will be the only member of the research team aware of the subjects' group allocations.

A 'blinded' research assistant will administer the balance tests and will perform any data processing that involves subjective judgments.

Scripts will be used during testing to ensure that all subjects receive the same instructions.

Testing session between two training periods (T1) will take one week.


Condition Intervention
Falls
Device: Self Mobility Improvement in the eLderly by using the SMILING system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • gait analysis [ Time Frame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tinetti's performance-oriented mobility assessment (POMA score), CODEX test, GDS test [ Time Frame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test) ] [ Designated as safety issue: No ]
  • CODEX test [ Time Frame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test) ] [ Designated as safety issue: No ]
  • GDS test [ Time Frame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: balance treatment Device: Self Mobility Improvement in the eLderly by using the SMILING system
The effect of treatment with the SMILING system on postural stability and gait of elderly individuals will be measured using RCT cross over study design

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

The inclusion criteria are:

Self-reported information

  1. age ≥ 65 years,
  2. able to walk at least 20 meters independently, i.e., without personal assistance and without an assistive device, except for a single point cane
  3. one or more falls in the previous year (falls during sport activities excluded).

Standardized physical and cognitive functional tests

  1. Tinetti's POMA score below 26 (strictly)
  2. MMSE test with score ≥ 24
  3. GDS test with score <10

The exclusion criteria are:

  1. Self-reported information
  2. age < 65 years
  3. inability to walk 20 meters safely (self-report) or walk with personal assistance or with an assistive device (except single point cane for fallers)
  4. inability to recall fall status in the previous year
  5. severe visual impairment (e.g., impaired ability to read, watch TV, or drive a car)
  6. severe hearing impairment (e.g., unable to follow a conversation, to use a phone)
  7. Standardized physical and cognitive functional tests
  8. Tinetti's POMA score less than 19
  9. MMSE score < 24
  10. GDS test with score ≥ 10
  11. Medical conditions (filled in by the family doctor of the subject)
  12. wearing a pacemaker, a cardiac defibrillator or any other electronic implant
  13. severe gait impairment precluding safe walking over 20 meters due to:
  14. focal lower limb muscle weakness or palsy (e.g., unable to raise leg/foot from floor)
  15. neurological diseases, including diseases such as severe Parkinson's disease, Multiple Sclerosis, status post stroke with hemi-syndroma, cervical or lumbar stenosis with compression myelopathy, polyneuropathy with severe proprioceptive impairment, Menier
  16. severe cardiovascular disease
  17. foot problems, lower limb amputation or joint arthrodesis
  18. terminal diseases (defined as estimated life expectancy of less than 6 months).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877721

Locations
Israel
SorokaUMC
Beer-Sheva, Israel, 84105
Sponsors and Collaborators
Soroka University Medical Center
European Union
Investigators
Study Chair: Yakov Grinshpon, MD Soroka University Medical Center
Principal Investigator: Itshak Melzer, PhD Ben-Gurion University of the Negev
  More Information

No publications provided

Responsible Party: Itshak Melzer PhD, PT, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00877721     History of Changes
Other Study ID Numbers: SOR483209CTIL, MZ4832
Study First Received: April 7, 2009
Last Updated: September 19, 2010
Health Authority: Israel: Soroka University Medical Center

Keywords provided by Soroka University Medical Center:
Postural Control
Gait
Falls
Elderly
Old adults (65 years old and older) with low risk of falls

ClinicalTrials.gov processed this record on September 16, 2014