Trials / Completed
CompletedNCT05079555
Effect of a Robotic Platform for Hip Fracture Rehab
Study of the Effect of Robotic Devices on the Functional Rehabilitation of Hip Fractures in Elderly People.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Werium Assistive Solutions · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
Hip fracture is one of the most common traumas associated with falls in the elderly, severely affecting the patient's mobility and independence. The treatment involves hospitalization and prolonged rehabilitation periods with high costs which are associated with an increased mortality rate due to health complications. In recent years, the use of robotic applications has proven to be effective in gait rehabilitation, especially for neurological disorders. However, there is a lack of research in robotic rehabilitation focused on the hip fracture of elderly people. This study presents the validation of a novel robotic platform for hip rehabilitation called SWalker aimed at improving the rehabilitation of this condition in comparison with conventional rehabilitation.
Detailed description
The performance of the SWalker platform was assessed at Albertia Servicios Sociosanitarios S.A. nursing homes. Clinical validation was conducted with hip fracture patients. The control group consisted of patients who followed conventional therapy, while the intervention group consisted of patients rehabilitated using SWalker. Allocation to groups was according to the choice of the participants. All patients had the possibility to use SWalker treatment. Physiological parameters, and functional assessment scales such as FAC and Tinetti were collected at the beginning and at the end of the intervention. Gait recovery and rehabilitation process indicators were also gathered. The total duration of the clinical validation was 15 months. For each patient, the total duration of treatment was between 1 week and 1 month with the robotic platform. For those patients who received conventional rehabilitation, treatment duration was up to 6 months in the most severe case. Patient follow-up was conducted in parallel with the clinical trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robotic rehab | Patients using the robotic platform SWalker |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2020-04-15
- Completion
- 2020-04-15
- First posted
- 2021-10-15
- Last updated
- 2021-10-15
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05079555. Inclusion in this directory is not an endorsement.