BALANSEAT RCT study on seated balance training with the Balanseat device in older people

BALANSEAT RCT study on seated balance training with the Balanseat device in older people - Balanseat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52787

Enrollment

Registered

2020-12-17

Start date

2021-05-21

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gerontologie, ouderdoms gerelateerde mobiliteits/balans problemen balance and gait

Interventions

one group receives 15 minutes of exercise with the Balanseat (used as intended), twice a week, over 6 weeks (total of 12 sessions) and are given regular advice on healthy lifestyle (eg. staying acti

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age 65+ years • Ability to walk at least 10 meters on a *at surface, with or without an assistive device • Decreased walking speed; gait speed

Exclusion criteria

Exclusion criteria: • Individuals with a major disease or unstable health that prevents their participation • Individuals with amputees or who had surgery in the past three months • Individuals following physical therapy related to back, walking and/or balance problems • Individuals with MCI or dementia

Design outcomes

Primary

Measure	Time frame
- Therapy adherence; Adherence to the intervention will be assessed based on adherence to the balanseat program during the study. Adherence to the balanseat program will be calculated based on completion of exercise bouts. - Gait and balance parameters to be measured before, during (after 6 sessions) and after the intervention (post 12 sessions) include; timed up and go (TUG), 10 meter walk test (10MWT), short physical performance battery (SPPB), functional reach test (FRT) and Falls efficacy scale (FES).	—

Measure

Time frame

- Therapy adherence; Adherence to the intervention will be assessed based on adherence to the balanseat program during the study. Adherence to the balanseat program will be calculated based on completion of exercise bouts. - Gait and balance parameters to be measured before, during (after 6 sessions) and after the intervention (post 12 sessions) include; timed up and go (TUG), 10 meter walk test (10MWT), short physical performance battery (SPPB), functional reach test (FRT) and Falls efficacy scale (FES).

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Secondary

Measure	Time frame
General mobility, quality and quantity of walking and quality and quantity of chair rises measured with the GoSafe device. One week before the Balanseat intervention, participants from the intervention group will start wearing the GoSafe device to enable a reliable measure of the pre-intervention phase. Participants will continue wearing the GoSafe device throughout the intervention period, and until one week after the intervention period, to enable a reliable measure of the post-intervention phase. The control group will undergo the same assessments and wear the GoSafe device the same amount of time compared to the intervention group.	—

Measure

Time frame

General mobility, quality and quantity of walking and quality and quantity of chair rises measured with the GoSafe device. One week before the Balanseat intervention, participants from the intervention group will start wearing the GoSafe device to enable a reliable measure of the pre-intervention phase. Participants will continue wearing the GoSafe device throughout the intervention period, and until one week after the intervention period, to enable a reliable measure of the post-intervention phase. The control group will undergo the same assessments and wear the GoSafe device the same amount of time compared to the intervention group.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)