CClinicalTrials.gg
CompletedNCT05317377Updated Apr 7, 2022

Leap Motion In Geriatric Rehabilitation

An interventional study of Exercise Therapy and Leap Motion Based Exergame in Elderly, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Elderly
03

In context

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 50 years old and over,
  • having adequate hand function,
  • ability to follow commands,
  • 24\< points in MMSE

Exclusion criteria

Exclusion Criteria:

  • presence of exercise contraindications
  • 14 or more points on the Geriatric Depression Scale
  • diagnosis of dementia
  • recent (acute) hand or arm injury
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Other: Exercise Therapy

  • 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.

    Device: Leap Motion Based Exergame

Interventions

  • OtherExercise Therapy

    Structured exercises focused on hand functionality

  • DeviceLeap Motion Based Exergame

    Appropriate games from Leap Motion Based Exergame system focused on hand functionality

06

What researchers measure

Primary outcomes

  1. Grip Strength Test

    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.

    Time frame: changes after 8 weeks

Secondary outcomes

  1. Pittsburgh Rehabilitation Participation Scale

    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.

    Time frame: changes after 8 weeks

  2. World Health Organization Quality of Life Instrument-Older Adults Module

    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.

    Time frame: changes after 8 weeks

  3. Digit Span Test

    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.

    Time frame: changes after 8 weeks

  4. Duruöz Hand Index

    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.

    Time frame: changes after 8 weeks

  5. Stroop Test

    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.

    Time frame: changes after 8 weeks

  6. Purdue Pegboard Test

    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.

    Time frame: changes after 8 weeks

  7. Box and Block Test

    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.

    Time frame: changes after 8 weeks

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, 34815, Turkey
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05317377
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
Farzin Hajebrahimi, PhD (Principal Investigator, Istanbul Medipol University Hospital) — Principal investigator
First posted
Apr 7, 2022
Start date
Jul 5, 2021
Primary completion
Feb 15, 2022
Completion
Mar 10, 2022
Last update
Apr 7, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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