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Completed

NCT Number: NCT00877721

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SorokaUMC

Beersheba, 84105, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria are:

Self-reported information

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

Standardized physical and cognitive functional tests

  • Tinetti's POMA score below 26 (strictly)
  • MMSE test with score ≥ 24
  • GDS test with score <10

The exclusion criteria are:

  • Self-reported information
  • age < 65 years
  • inability to walk 20 meters safely (self-report) or walk with personal assistance or with an assistive device (except single point cane for fallers)
  • inability to recall fall status in the previous year
  • severe visual impairment (e.g., impaired ability to read, watch TV, or drive a car)
  • severe hearing impairment (e.g., unable to follow a conversation, to use a phone)
  • Standardized physical and cognitive functional tests
  • Tinetti's POMA score less than 19
  • MMSE score < 24
  • GDS test with score ≥ 10
  • Medical conditions (filled in by the family doctor of the subject)
  • wearing a pacemaker, a cardiac defibrillator or any other electronic implant
  • severe gait impairment precluding safe walking over 20 meters due to:
  • focal lower limb muscle weakness or palsy (e.g., unable to raise leg/foot from floor)
  • 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
  • severe cardiovascular disease
  • foot problems, lower limb amputation or joint arthrodesis
  • terminal diseases (defined as estimated life expectancy of less than 6 months).

Treatment and study plan

Self Mobility Improvement in the eLderly by using the SMILING system

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Collaborators

  • European Union

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 8, 2009
Registry last updated
Sep 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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