Protocol summary

Summary
The main purpose of this study is to find which type of treatment (cognitive-motor intervention or virtual reality method) is more effective to improve the postural control of older adults. It is estimated 20 healthy older adults are sufficient for this study. The inclusion criteria for healthy older adults are the following: Age ≥ 65 years old, be free from any severe cardiopulmonary disease, neurological disorder, musculoskeletal impairment or any history of falls in the prior 6 months. Subjects are excluded from either group if had any dizziness, fatigue, vigorous physical activity or stress before testing. After baseline evaluation, subjects are randomly allocated to one of the two groups: (1) cognitive-motor dual-task training, (2) virtual reality based training. Cognitive-motor dual-task training is balance training while simultaneously engaging in a secondary cognitive task. Virtual reality based training is balance training in a virtual environment using programs of Wii fit. Participants in these groups are attended 12-16 sessions, 3 sessions per week, and 60 minutes per session. The outcome measurements take place at 3 time points: (1) before initiation of intervention (baseline), (2) after completion of training, (3) 8 weeks after completion of training. The outcome measurements are initial swing step time, initial stance step time, initial swing step time variability, initial stance step time variability, verbal reaction time, verbal reaction accuracy, and attention allocation index of these parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015052022341N1
Registration date: 2015-05-26, 1394/03/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-26, 1394/03/05
Registrant information
Name
Roya Khanmohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 5088
Email address
rkhanmohammadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-05-26, 1394/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of motor-cognitive dual task training and virtual reality based training effects on the attentional demands of gait initiation in older adults
Public title
Comparison of motor-cognitive dual task training and virtual reality based training effects on the attentional demands of gait initiation in older adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age ≥ 65 years old; BBS score >40; TUG score ≤20; ABC score ≥50%; MMSE score ≥24; HADS- depress subscale score ≤7; Have no severe cardiopulmonary disease, neurological disorder and musculoskeletal impairment; Have no history of falls in the prior 6 months Exclusion criteria: had vigorous physical activity before testing; had dizziness, fatigue, and stress during testing
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-08-03, 1392/05/12
Ethics committee reference number
130/888/د/92

Health conditions studied

1

Description of health condition studied
elderly
ICD-10 code
G31.1
ICD-10 code description
Senile degeneration of brain, not elsewhere classified

Primary outcomes

1

Description
Initial swing step time
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
foot switch sensor- software of Biometrics DataLog

2

Description
Initial stance step time
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
foot switch sensor- software of Biometrics DataLog

3

Description
Initial swing step time variability
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
foot switch sensor- excel software

4

Description
Initial stance step time variability
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
foot switch sensor- excel software

5

Description
Verbal reaction time
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
Recorder - Sound Forge Pro

6

Description
Verbal reaction accuracy
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
Recorder - Sound Forge Pro

7

Description
Attention allocation index
Timepoint
before training, after completion of training, 8 weeks after completion of training
Method of measurement
excel software

Secondary outcomes

empty

Intervention groups

1

Description
Balance training while simultaneously engaging in a secondary cognitive task. Participants in this group are attended 12-16 sessions, 3 sessions per week, and 60 minutes per session.
Category
Behavior

2

Description
Balance training in a virtual environment using programs of Wii fit. Participants in this group are attended 12-16 sessions, 3 sessions per week, and 60 minutes per session.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Faculty
Full name of responsible person
Roya Khanmohammadi
Street address
Tehran-enghelab street- piche shemiran- Physical Therapy Department
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rehabilitation Faculty
Full name of responsible person
Dr. Saeed Talebian
Street address
Tehran-enghelab street- piche shemiran- Physical Therapy Department
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehabilitation Faculty
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Roya Khanmohammadi
Position
Phd student
Other areas of specialty/work
Street address
Tehran-enghelab street- piche shemiran- Physical Therapy Department
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
rkhanmohammadi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Saeed Talebian
Position
Professor
Other areas of specialty/work
Street address
Tehran-enghelab street- piche shemiran- Physical Therapy Department
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
Talebian@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Roya Khanmohammadi
Position
Phd student
Other areas of specialty/work
Street address
Tehran- enghelab street- piche shemiran- Rehabilitation faculty- Physical Therapy Department
City
Tehran
Postal code
Phone
+98 21 7768 5088
Fax
Email
rkhanmohammadi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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