ElderlyNCT05317377
Leap Motion In Geriatric Rehabilitation
A study testing Exercise Therapy and Leap Motion Based Exergame in people with Elderly, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Exercise Therapy and Leap Motion Based Exergame
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2021to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years old and over,
- having adequate hand function,
- ability to follow commands,
- 24< points in MMSE
Who cannot join
- presence of exercise contraindications
- 14 or more points on the Geriatric Depression Scale
- diagnosis of dementia
- recent (acute) hand or arm injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Elderly
- Being tested
- Exercise Therapy, Leap Motion Based Exergame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyOther
Structured exercises focused on hand functionality
Leap Motion Based ExergameDevice
Appropriate games from Leap Motion Based Exergame system focused on hand functionality
| Study group | Role | What they receive |
|---|---|---|
| Structured Exercise | Active comparator | 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. Receives: Other: Exercise Therapy |
| Leap Motion Based Exergame (LMBE) | Experimental | "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. Receives: Device: Leap Motion Based Exergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: changes after 8 weeks
Secondary outcomes (7)
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.
Measured: changes after 8 weeks
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.
Measured: changes after 8 weeks
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.
Measured: changes after 8 weeks
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.
Measured: changes after 8 weeks
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.
Measured: changes after 8 weeks
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.
Measured: changes after 8 weeks
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.
Measured: changes after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start5 Jul 2021
- Primary completion15 Feb 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farzin Hajebrahimi, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317377
- Sponsor's protocol ID
- LeapGeriatric2021
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leap Motion Controller Based Exergame Therapy in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT05317377
- Acronym / sponsor ID
- LeapGeriatric2021
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Exercise | Active comparator | Other: Exercise TherapyStructured 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. |
| Leap Motion Based Exergame (LMBE) | Experimental | Device: Leap Motion Based Exergame"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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years old and over,
- having adequate hand function,
- ability to follow commands,
- 24< points in MMSE
Key exclusion criteria (4 listed)
- presence of exercise contraindications
- 14 or more points on the Geriatric Depression Scale
- diagnosis of dementia
- recent (acute) hand or arm injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapyStructured exercises focused on hand functionality | Other | Structured Exercise |
| Leap Motion Based ExergameAppropriate games from Leap Motion Based Exergame system focused on hand functionality | Device | Leap Motion Based Exergame (LMBE) |
Primary outcome
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.
7 secondary outcomes
Pittsburgh Rehabilitation Participation Scale
Time frame: changes after 8 weeks
World Health Organization Quality of Life Instrument-Older Adults Module
Time frame: changes after 8 weeks
Digit Span Test
Time frame: changes after 8 weeks
Duruöz Hand Index
Time frame: changes after 8 weeks
Stroop Test
Time frame: changes after 8 weeks
Purdue Pegboard Test
Time frame: changes after 8 weeks
Box and Block Test
Time frame: changes after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy and Leap Motion Based Exergame in people with Elderly, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength Test (time frame: changes after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.