NCT07507279

Brief Summary

Because hand and cognitive functions decline in the elderly, intervention programs addressing these problems are necessary. In recent years, creating rehabilitation programs using technology has gained popularity. The aim of this study is to examine the effects of technology-based rehabilitation using LMC (Light Mood Enhancer) and dual upper extremity tasks on joint position sense, grip strength, functionality, and executive functions in elderly individuals; and to compare these effects with those of an exercise program performed solely with an LMC device and a control group consisting of a hand rehabilitation program performed with a physiotherapist. The research is a randomized controlled trial and will consist of 3 groups. After randomization, individuals' joint position sense, gross and fine grip strength, functionality, and executive functions will be evaluated. Evaluations will be performed twice, at the beginning and end of the 8-week program.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 23, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 23, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

older adultshand rehabilitationtechnologydual task

Outcome Measures

Primary Outcomes (5)

  • Joint sense position

    Wrist joint position sense of individuals will be assessed using a digital inclinometer. In this method, the individual will be actively guided to the desired position by the physiotherapist, held in that position for 5 seconds, and asked to remember the position. The individual will then be asked to return their wrist to that position. Wrist position sense assessment will be based on the principle of actively repeating the predetermined target angle. All axes of movement of the wrist in flexion, extension, radial deviation, and ulnar deviation directions will be evaluated. The target angles used in the assessment will be determined as 30° for flexion and extension, 10° for radial deviation, and 15° for ulnar deviation. The angle of the participant's wrist in all axes of movement will be noted, and the absolute difference between this angle and the target angle will be recorded as the "Joint Position Sense Error Amount"

    Just before the treatment begins and at the end of the 8th week

  • Hand function

    The Nine-Hole Peg Test (9HPT) is a standardized, timed, quantitative assessment of fine manual dexterity. The test requires placing 9 pegs into holes on a board one-by-one and then removing them, using one hand at a time, to measure hand-eye coordination and finger speed. Less time means better performance.

    Just before the treatment begins and at the end of the 8th week

  • Hand function

    Jebsen hand function tes will be used for hand function. It is a standardized, clinician-administered assessment designed to measure fine motor, gross motor, and weighted hand function using simulated activities of daily living (ADLs). Special equipment and a stopwatch are provided for the tests. Separate times are recorded for each task given for scoring purposes. It consists of seven timed subtests performed on both hands-starting with the non-dominant hand-to evaluate speed rather than movement quality, with higher times indicating lower function.

    Just before the treatment begins and at the end of the 8th week

  • Grip strength

    Dynamometer and pinchmeter will be used for gross and fine grip strength. The measurement will be repeated three times. A 15-second break will be given after each measurement. Finally, the average of the three measurements will be recorded.

    Just before the treatment begins and at the end of the 8th week

  • Hand function

    The Purdue Pegboard Test is a standardized, 5-10 minute assessment used to measure fine and gross motor dexterity of the hands, fingers, and arms. It requires individuals to place small metal pins, collars, and washers into holes on a vertical board using the right hand, left hand, and both hands simultaneously, commonly applied in rehabilitation and hiring for manual labor. The more pins that are installed within the specified time, the better the performance.

    Just before the treatment begins and at the end of the 8th week

Secondary Outcomes (1)

  • Stroop test

    Just before the treatment begins and at the end of the 8th week

Study Arms (3)

Technological hand rehabilitation group

EXPERIMENTAL

they will take only technological hand rehabilitation

Other: Technological hand rehabilitation exercises

Dual task group

EXPERIMENTAL

They will take dual task and technological hand rehabilitation

Other: Dual task with technological hand exercises

Home exercise group

OTHER

They will do hand exercises at home

Other: Home exercises

Interventions

Elderly individuals in this group will play the games mentioned above for 45 minutes a day, 2 days a week, for 8 weeks, using only their hands via a computer with an LMC device, under the supervision of a physiotherapist. The procedure will be the same as for the other group, as described above. The intervention will be carried out with ball games for the first 4 weeks, and helicopter and airplane games will be added in the following 4 weeks. The elderly individual will play these games with both their dominant and non-dominant hands. The playing time will be equal for both hands. The elderly individuals will be able to take as many breaks as they wish during the games. The number of repetitions of the games will be increased each week according to the elderly individual's progress.

Technological hand rehabilitation group

A rehabilitation program consisting of stretching and strengthening exercises will be applied to individuals under the guidance of a physiotherapist experienced in geriatric rehabilitation. The program will include hand flexion, extension, radial and ulnar deviation, and finger movements. Therabands and resistance bands will be used for strengthening. The number of repetitions of the exercises will be increased each week. The rehabilitation program will be applied for 45 minutes a day, 2 days a week, for 8 weeks.

Home exercise group

Hand exercises will be conducted with the guidance of a physiotherapist using the Leap Motion Controller (LMC). These exercises will be performed twice a week for eight weeks, with each session lasting 45 minutes. While the elderly are playing games on a computer using their hands via the LMC device, dual-task training will be provided by physiotherapists. The dual-task training will be implemented as follows: In the first week, while the elderly are performing hand exercises via the LMC, they will be given one verbal, one arithmetic, and one auditory task. In subsequent weeks, the number of verbal, arithmetic, and auditory tasks will be increased by one task each week. Thus, the training will be gradually made more challenging. In addition, the dual-task training can be individualized according to the elderly's initial cognitive level and progress. Technology-based hand exercises will be performed with games specific to the LMC.

Dual task group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age and older
  • Not receiving hand-related physiotherapy and rehabilitation
  • Ability to follow instructions,
  • Scoring 24 points or more on the Mini Mental Test

You may not qualify if:

  • Having a neuropsychiatric diagnosis
  • Acute hand and arm injury
  • Having a diagnosis of rheumatological and orthopedic diseases affecting the hand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

Related Publications (1)

  • Arman N, Oktay AB, Tarakci D, Tarakci E, Akgul YS. The validity of an objective measurement method using the Leap Motion Controller for fingers wrist, and forearm ranges of motion. Hand Surg Rehabil. 2021 Sep;40(4):394-399. doi: 10.1016/j.hansur.2021.03.007. Epub 2021 Mar 26.

Central Study Contacts

Sebahat Yaprak Cetin, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 2, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

September 25, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

I will plan to share IPD with other researchers via email and using SPSS program for statistic

Shared Documents
STUDY PROTOCOL, SAP

Locations