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NCT03651297
Simple Fall-Arrest Harness vs. Adjustable Harness
NA trial testing Balance training with Fall-Arrest harness in Fall Accident in 40 participants. Suspended.
31 July 2022
Quick facts
| Lead sponsor | Cleveland State University |
|---|---|
| Phase | NA |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 20 November 2018 |
| Primary completion | 31 July 2022 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Balance training with Fall-Arrest harness
- Balance training with Adjustable harness
Conditions studied
- Fall Accident — all drugs for Fall Accident →
- Fall Injury — all drugs for Fall Injury →
- Balancing Interference — all drugs for Balancing Interference →
Sponsor
Cleveland State University
Who can join
18 and older, any sex, with Fall Accident or Fall Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fall risk increases with age and the fear of falling can significantly impact activity, mobility and future fall risk. Exercise designed specifically to help balance is effective at improving balance and postural control for mobility, gait, and other daily activities. The individual purposes of this research are to (1) effectively use a prototype of an instrumented and actuated harness and support system, (2) demonstrate that this system can be used as designed during induced falls (reactive) and in place gaming (proactive) balance training protocols with the ability to modulate parameters as designed, measurements of harness system are accurate, and resultant output of the system matches intended parameters, and (3) demonstrate that the use of this system can allow provision of and study of varied balance training protocols, including: the measurements of the system, feedback of the system to participants, and the impact of the support parameters of the harness system on the task execution, learning and transfer. Two separate groups of 20 participants (40 total participants) will be studied. The first group will include 20 individuals between the ages of 18 to 40 years old with no history of falls or fear of falling. The first group will complete two sessions of harnessed video gaming balance training. The second group will include older adults over the age of 55 with self-reported falls or the fear of falling. The second group of older adults will complete two sessions of a reactive (slip) training protocol. For both groups, the first session participants will be randomly assigned to use either a standard fall-arrest harness or the new BWS harness system. At the second session, they will switch the harness used. The protocol will involve slips or gaming based balance training, initially of low intensity and then advanced by algorithm based on their response to the trial just prior. This will allow comparison of postural control, perturbation responses, motor learning, and confidence with the system between the two harness types.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT03651297
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Related trials
Other recruiting trials for Fall Accident
Currently open trials in the same condition.
- NCT07216846 — The Geriatric Emergency Department Pharmacologic Harm Prevention Project · NA · recruiting
Other Cleveland State University trials
Trials by the same sponsor.
- NCT07519096 — Steady Together Fall Prevention Program in the Home · NA · recruiting
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- NCT05451706 — Improving College Students' Mental Help-Seeking Intention During the COVID-19 Pandemic · NA · completed
- NCT03170102 — Building Capacity of OT Students to Address Children's Mental Health During Fieldwork (OTFW) · NA · completed
- NCT03173209 — Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03651297 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cleveland State University
- Last refreshed: 6 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03651297.
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