- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317377
Leap Motion In Geriatric Rehabilitation
March 30, 2022 updated by: Farzin Hajebrahimi, PhD, Istanbul Medipol University Hospital
Leap Motion Controller Based Exergame Therapy in Geriatric Individuals
Little is Known about the effects of leap motion based exergame therapy on different functions of elderly adults.
The purpose of this study was to evaluate the effect of leap motion based exergame therapy on hand function, cognitive function and quality of life in older adults
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34815
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 50 years old and over,
- having adequate hand function,
- ability to follow commands,
- 24< points in MMSE
Exclusion Criteria:
- presence of exercise contraindications
- 14 or more points on the Geriatric Depression Scale
- diagnosis of dementia
- recent (acute) hand or arm injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Structured Exercise
Structured hand exercises will be applied in 45-minute sessions (16 sessions total), 2 days a week, over 8 weeks in addition to participants' routine physical activities.
|
Structured exercises focused on hand functionality
|
|
Experimental: Leap Motion Based Exergame (LMBE)
"ErgoActive" and "HandROM" exercise apps focusing on hand exercises and fine motor skills will be applied in 45-minute session (16 sessions total), 2 days a week, over 8 weeks in addition to participants' routine physical activities.
|
Appropriate games from Leap Motion Based Exergame system focused on hand functionality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip Strength Test
Time Frame: changes after 8 weeks
|
A hand dynamometer (pinch meter gauge; Jamar® Hand Dynamometer - Hydraulic - 200 lb Capacity.
Patterson Medical Illinois, USA) will be used to determine the grip strength of the participants.
While taking the measurements, the patients will be seated with the shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm and wrist in neutral position.
Each grip test will be repeated three times and the highest score for the affected extremity will be used for further analysis.
|
changes after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Rehabilitation Participation Scale
Time Frame: changes after 8 weeks
|
It is a clinician-evaluated outcome scale that examines the patient's participation in therapy and motivation.
While the test period lasts 5 minutes, it consists of 6 different scores (1-none/6-excellent). Higher scores mean better performance.
|
changes after 8 weeks
|
|
World Health Organization Quality of Life Instrument-Older Adults Module
Time Frame: changes after 8 weeks
|
It is a versatile scale that helps to evaluate the quality of life in elderly individuals.
WHOQOL-OLD consists of 6 sections: sensory skills, autonomy, past-present-future activities, social participation, death and relationships, and includes 4 items in each section, consisting of a total of 24 questions.
|
changes after 8 weeks
|
|
Digit Span Test
Time Frame: changes after 8 weeks
|
It consists of two sub-categories, forward and backward number range, and evaluates attention .
During the test, the participant is asked to repeat the numbers from 1 to 9 in mixed order, starting from 4 and increasing to 8. At this time, it is important to note that each number is said in one second, slowing down may develop different strategies.
The forward range consists of 5 to 7 numbers, while the reverse range consists of 3 to 7 numbers.
The participant is asked to count forward or backward from the number said.
As many points as they can say are noted as a score.
|
changes after 8 weeks
|
|
Duruöz Hand Index
Time Frame: changes after 8 weeks
|
It is an 18-item, self-answered scale that evaluates hand activity limitations and its effect on activities of daily living.
In the scale where scores between 0-90 can be obtained, high scores indicate low function.
|
changes after 8 weeks
|
|
Stroop Test
Time Frame: changes after 8 weeks
|
The Stroop Test measures the processing speed, the ability to suppress habitual behavior, focused attention, the ability to do unusual behavior, the ability to change the perceptual setup according to changing demands, and under a disturbing effect.
The tests proved to be reliable (with test/retest reliabilities ranging from acceptable (r=0.63) to high (r=0.88)
and sensitive to detect small differences in subjects from different age categories.
|
changes after 8 weeks
|
|
Purdue Pegboard Test
Time Frame: changes after 8 weeks
|
The Purdue Pegboard consists of a board with holes into which metal pegs are inserted by the patient.
It also comes with washers and collars to be placed on the pins.
The test measures movements, coordination and speed of hand and finger dexterity.
In the test procedures, the patient is first asked to use the right hand to properly insert as many pins as possible in the holes.
Then, the same procedure is repeated for the left hand.
In the final stage the patient is given 60 sec to place the pins, washers and collars using both hands.
|
changes after 8 weeks
|
|
Box and Block Test
Time Frame: changes after 8 weeks
|
It examines unilateral gross motor skills.
A stopwatch, a wooden box with a middle section, and 150 wooden cubes are the required materials.
The total duration of the test is 2-5 minutes.
The test can be applied between the ages of 6 and 65.
Within 60 seconds, which is kept by the stopwatch, it is requested to pass the cubes one by one from one compartment to the other and the number of cubes is noted.
This test is applied separately for both extremities.
|
changes after 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2021
Primary Completion (Actual)
February 15, 2022
Study Completion (Actual)
March 10, 2022
Study Registration Dates
First Submitted
March 14, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- LeapGeriatric2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data that support the findings of this study will be available on reasonable request from the principle investigator.
The data are not publicly available due to ethical issues.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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