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NCT05110300 · ClinicalTrials.gov registry record · NA
A Multisite Exploration of Balance Perturbations With and Without Body Weight Support
A NA study, sponsored by Gaylord Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 114
- Enrollment target
NCT05110300 is a NA study that was terminated before completion, run by Gaylord Hospital. The registered enrollment target is 114 participants.
The verdict
NCT05110300, a NA study, was terminated before completion, sponsored by Gaylord Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 114 participants
- Enrollment target
Study Summary
ZeroG is an FDA-listed robotic body weight support system (BWSS). Mounted on an overhead track, patients are fitted in a harness system tethered to said track, and are able to practice gait and balance activities without the risk of falling. This compensates for ineffective postural control permitting intensive therapy sessions earlier in recovery. The purpose of this study is to determine if inducing effective and safe balance perturbations during standing and walking in the BWSS more effectively improve postural control than the BWSS without perturbations. The target population are those patients in the post-acute phase of stroke admitted for inpatient rehabilitation of balance impairments. Site investigators and/or research staff will obtain names of potential subjects from internal reporting identifying inpatients who may qualify for the study based on the inclusion criteria. Trained site investigators will meet with potential subjects to explain the study, complete a screening interview for exclusion and inclusion criteria, answer any questions, obtain informed consent and HIPAA authorization, and schedule the study therapy sessions involving the protocol. Based on the randomization scheme provided by the lead site, consented subjects will be randomized to either the BWSS with perturbations (BWSS-P) or standard BWSS control without perturbations. Subjects will perform 2 to 6 sessions in their designated intervention using a structured protocol for each session. To compare differences between treatment groups, outcome measures will be collected at baseline before any BWSS sessions are performed and within 48 hours after completing the final treatment session.
Interventions
- DEVICE Body weight support system control group
- DEVICE Body weight support system with balance perturbations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-12-15 |
| Est. Completion | 2023-11-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05110300
The ClinicalTrials.gov registry entry for NCT05110300 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gaylord Hospital, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Body weight support system control group is the first listed.
NCT05110300 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05110300 about?
NCT05110300 is a clinical study titled "A Multisite Exploration of Balance Perturbations With and Without Body Weight Support". ZeroG is an FDA-listed robotic body weight support system (BWSS). Mounted on an overhead track, patients are fitted in a harness system tethered to said track, and are able to practice gait and balance activities without the risk of falling. This compensates for ineffective postural control permitti...
What is the current status of trial NCT05110300?
This trial is currently terminated. It is a NA study. The enrollment target is 114 participants. The study started on 2021-12-15. Estimated completion is 2023-11-06.
What interventions are being tested in trial NCT05110300?
The interventions under investigation include: Body weight support system control group (DEVICE), Body weight support system with balance perturbations (DEVICE).
Who is sponsoring clinical trial NCT05110300?
This trial is sponsored by Gaylord Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov.
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