Clinical Trials Directory

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

TypeNameDescription
DEVICERobotic rehabPatients 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.