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

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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