To test the consistency, accuracy and sensibility of Pedalo® -Sensamove-Balance Device in older adults.

Not yet recruiting

• Conditions: Healthy Older Adults

• Registration Number: CTRI/2023/03/050682
• Lead Sponsor: Jamia Millia Islamia

Brief Summary

Alternate hypothesis of the study - Pedalo® Sensamove Balance Device will be a reliable, valid and responsive device to measure balance outcomes in community dwelling older adults.

Before the initiation of the study, approval taken from the institutional ethical committee, Jamia Millia Islamia, New Delhi. Participants will be informed that participating in this study is voluntarily and that they will be free to leave the study at any time. Posters inviting for voluntary participation of older adults will be distributed at recreational centers, senior residences, parks from nearby communities and Jamia Millia Islamia.

Participants will be recruited from Jamia Millia Islamia and community and informed consent would be signed. All identifying information and demographic data will be kept confidential. Following familiarization, first data will be collected for the  Pedalo® Sensamove Balance Device to measure COP range in all the four directions (front, back, left and right) and COP sway (Antero-posterior, medio-lateral). After that three clinical tests OLS, FRT and TUG will be performed for the Validity. Second readings for balance measures COP range and COP sway will be collected using  Pedalo® Sensamove Balance Device after a gap of 3 days to check the Test-Retest Reliability. Participants will perform 4- weeks of balance exercises at home and after completion of exercises, the final readings for COP range and COP sway will be collected using  Pedalo® Sensamove Balance Device to find the responsiveness of the same balance device.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-13
• Study Start: 2023-03-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Age above 60 years MMSE score equal to or more than 25 Walk independently.

Exclusion Criteria

• Any orthopedic surgery of the lower limb, spine and pelvis within 6 months.
• Any implants in the axial skeleton lower limb Any visual or auditory impairment without correction Unstable acute or chronic medical condition (severe hypertension, uncontrolled diabetes, vertebrobasilar insufficiency) Acute illness within the past 3 weeks ( MI, stroke,) History of or symptoms of any neurological or vestibular disorder Any medication that affects the balance mechanism Criteria for frailty based on grip strength, gender and body mass index (BMI).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Centre of pressure (COP) Range,	for test-retest reliability at day 1 and after 3 days | for responsiveness- after 4 weeks
2) Centre of pressure (COP) Sway	for test-retest reliability at day 1 and after 3 days | for responsiveness- after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Functional Reach Test (FRT)	One leg standing (OLS)

Trial Locations

Locations (1)

Jamia Millia Islamia; 🇮🇳 South, DELHI, India

Jamia Millia Islamia

🇮🇳South, DELHI, India

Dr Zubia Veqar

Principal investigator

9958993486

veqar.zubia@gmail.com