Protocol summary
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Study aim
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Study and compare the effects of single and dual-task balance and gait training on gait harmonic ratio and functional balance in older adults and taking advantage of the outcomes to improve gait and balance and decrease the risk of falling
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Design
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A randomized, single-blind clinical trial with a parallel group design. The subjects are randomized with Permuted Block into three groups (two interventional and one control groups).
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Settings and conduct
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Subjects are recruited from the older adults who refer to Jahandidegan Center in Shiraz city.
the study is single-blinded and the assessor of balance and gait outcome is unaware of subjects allocation to the groups.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
age of 65 years old or more, obtain score 24 or more out of 30 in MMSE and score lower than 7 in GDS, the ability to walk without assistive devices for at least 20 meters
exclusion criteria:
neurologic, orthopedic and musculoskeletal disorders that can affect gait, history of head injury, cardiovascular and respiratory disorders, chest pain with activity, cancer, history of surgery in lower limbs, spinal column or head during the past 6 months and the need to use Oxygen capsule
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Intervention groups
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group 1: single-task training (6 weeks of single-task balance and gait training)
group 2: dual-task training (6 weeks of dual-task balance and gait training)
group 3: control group (without intervention)
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Main outcome variables
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Fullerton Advanced Balance scale (FAB); Timed Up & Go test; Activities-specific Balance Confidence، gait performance under single- and dual-task conditions
General information
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Reason for update
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The actual recruitment dates were added.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180429039470N1
Registration date:
2018-06-17, 1397/03/27
Registration timing:
prospective
Last update:
2020-12-13, 1399/09/23
Update count:
2
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Registration date
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2018-06-17, 1397/03/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-12, 1397/03/22
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Expected recruitment end date
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2018-08-21, 1397/05/30
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Actual recruitment start date
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2018-06-30, 1397/04/09
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Actual recruitment end date
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2018-07-16, 1397/04/25
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Trial completion date
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2018-09-23, 1397/07/01
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Scientific title
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Effects of single and dual-task balance and gait training on gait harmonic ratio and functional balance in older adults
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Public title
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Effects of gait and balance training on gait and balance in older adults
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
age 65 years old or more
obtain score 24 or more out of 30 in MMSE
obtain score lower than 7 in GDS
the ability to walk without assistive devices for at least 20 meters
Exclusion criteria:
neurologic disorders including Parkinson's, MS, stroke, peripheral neuropathy that can affect gait performance
specific orthopedic and musculoskeletal disorders including knee replacement or fracture
history of head injury
cardiovascular and respiratory disorders
severe chronic pain and chest pain with activity
cancer
history of surgery in lower limbs, spinal column or head during the past 6 months
the need to use Oxygen capsule
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Age
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From 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
69
Actual sample size reached:
69
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted Block Randomization
Randomization was achieved with an online randomization application to provide random permuted blocks with a block size of 6.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessor of balance and gait outcome was unaware of subjects allocation to the groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-09, 1397/03/19
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Ethics committee reference number
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IR.AJUMS.REC.1397.212
Health conditions studied
1
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Description of health condition studied
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gait and balance in older adults
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ICD-10 code
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R26.89
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ICD-10 code description
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Other abnormalities of gait and mobility
Primary outcomes
1
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Description
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Gait performance
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Timepoint
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Baseline، at the end of the sixth week and 3 months after the trial
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Method of measurement
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Gait harmonic ratio
Secondary outcomes
1
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Description
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balance performance
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Timepoint
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Baseline, at the end of the sixth week and 3 months after the trial
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Method of measurement
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Fullerton advanced balance scale (FAB)
2
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Description
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Functional activity
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Timepoint
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baseline, at the end of the sixth week and 3 months after the trial
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Method of measurement
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Timed Up & Go test
3
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Description
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Balance confidence
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Timepoint
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Baseline, at the end of the sixth week and 3 months after the trial
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Method of measurement
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Activities-specific Balance Confidence scale
Intervention groups
1
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Description
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Intervention group 1: single-task gait and balance training This group will receive 6 weeks of balance training, 3 sessions per week. Each session will take 40-60 minutes and each exercise will repeat 5-8 times. Each exercise takes 30 seconds, with a 15-second rest between exercises.
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Category
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Rehabilitation
2
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Description
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Intervention group 2: dual-task gait and balance training This group will receive 6 weeks of balance training concomitant with a cognitive task (including naming, remembering and backward counting) , 3 sessions per week. Each session will take 40-60 minutes and each exercise will repeat 5-8 times. Each exercise takes 30 seconds, with a 15-second rest between exercises.
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Category
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Rehabilitation
3
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Description
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Control group: without intervention This group will receive no intervention during the 6-week period of the trial.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The data of the participant alone is useless.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The results of primary outcomes will be shared.
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When the data will become available and for how long
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two months after the publication of the results.
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To whom data/document is available
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academic researchers
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Under which criteria data/document could be used
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Once accessed, individuals have the right to use the study protocol for rehabilitation purposes.
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From where data/document is obtainable
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Samira Javadpour will be responsive through email. samira.javadpour@yahoo.com
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What processes are involved for a request to access data/document
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After receiving the request and mentioning the reasons for the request, the data will be answered within a maximum of one month.
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Comments
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