Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 1:15 AM
Ignite Modification Date: 2025-12-25 @ 1:15 AM
NCT ID: NCT06711393
Brief Summary: The mobility problems of older people are often related to the decrease of functional capacity and health \[1\], weakened physical condition, attitude to life and fear of falling \[2\]. Relatively little research has been done on the possibilities and effectiveness of exergaming on the mobility of old people. Interventions that include exergaming have been found to motivate and increase commitment to rehabilitation \[3\], to improve mobility, balance \[4\], performance in daily activities and independence \[5\]. The aim of randomized intervention trial is to find out the effect of physical exercises performed on the technological device (YetiHome®) on identified preclinical movement problems during a 2-month follow-up period. The goal is to produce information about the effectiveness of gamified physical exercises in preventing movement problems and supporting older people living at home. This study investigates the effectiveness of the YetiHome in improving the physical functioning of older people. YetiHome is an assistive technology device developed for special groups. YetiHome is a small interactive touchscreen tablet with 27" screen and with Android operating system and it includes numerous applications. Added exergaming solution for the balance training. There is no previous scientific research on the effectiveness of the YetiHome on the mobility problems and activity of the community-dwelling older people living independently at home. The aim of randomized intervention trial is to find out the effect of physical exercises performed on the technological device (YetiHome®) on identified preclinical movement problems during a 2-month follow-up period. The goal is to produce information about the effectiveness of gamified physical exercises in preventing movement problems and supporting older people living at home. This study investigates the effectiveness of the YetiHome in improving the physical functioning of older people. YetiHome is an assistive technology device developed for special groups. YetiHome is a small interactive touchscreen tablet with 27" screen and with Android operating system and it includes numerous applications. Added exergaming solution for the balance training. There is no previous scientific research on the effectiveness of the YetiHome on the mobility problems and activity of the community-dwelling older people living independently at home.
Detailed Description: Sample size calculation was completed based on an effect size of 0.35 (power = 0.80; α= 0.05). Assuming a 35% attrition rate, a total of 100 participants will be recruited (50 people in a control group and 50 people in the intervention group). The target group is 75 old people, who are not covered by social and health services and who have received a preventive home visit in the region of Kemi in northern Finland. The intervention groups consist of people who have been found to have preclinical mobility problems during a preventive home visit. After being informed about the study all suitable participants of the preventive home visit willing to participate in this study will undergo baseline functional testing on week 0. Same functional measurements will be conducted after two-month intervention period. Baseline data collection of functional capacity utilizes the structured questionnaire (HEKO-tool), whose functional assessment targets are bridged to the ICF classification (International Classification of Functioning, Disability and Health). Data is collected on everyday activities as well as mental-wellbeing, social-wellbeing and risk of falls. In the second phase, the physical performance was assessed by a One-Leg Balance test (OLB) and Short Physical Performance test (SPPB) combined with a mobile solution developed to measure balance, AinoneBalance. The AinoneBalance application utilizes Romberg's standardized test. The participants were randomized into a game group and a control group. The gaming group received a YetiHome® device at home and instructions for the traditional exercise. The control group only received instructions for the traditional exercise.
Study: NCT06711393
Study Brief:
Protocol Section: NCT06711393