NCT05317377

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 14, 2022

Last Update Submit

March 30, 2022

Conditions

Outcome Measures

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.

    changes after 8 weeks

Secondary Outcomes (7)

  • Pittsburgh Rehabilitation Participation Scale

    changes after 8 weeks

  • World Health Organization Quality of Life Instrument-Older Adults Module

    changes after 8 weeks

  • Digit Span Test

    changes after 8 weeks

  • Duruöz Hand Index

    changes after 8 weeks

  • Stroop Test

    changes after 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Device: Leap Motion Based Exergame

Interventions

Structured exercises focused on hand functionality

Structured Exercise

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

Leap Motion Based Exergame (LMBE)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will be included in the study and randomly divided into two groups using block randomization in Microsoft Excel 'RAND(WS)' function.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 7, 2022

Study Start

July 5, 2021

Primary Completion

February 15, 2022

Study Completion

March 10, 2022

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

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.

Locations