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Effect of a Robotic Platform for Hip Fracture Rehab

W

Werium Assistive Solutions

Status

Completed

Conditions

Hip Fractures

Treatments

Device: Robotic rehab

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT05079555
SWalkerRehab

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who, after recently having undergone a hip fracture surgery, needed subsequent rehabilitation to restore autonomous ambulation
  • patients over 65 years of age

Exclusion criteria

  • patients who have undergone a hip fracture surgery more than 5 months ago
  • patients who have already received other types of hip fracture rehabilitation therapies
  • patients with advanced and limiting neurological and cognitive impairment

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Control group
No Intervention group
Description:
The control group consisted of patients who followed conventional therapy.
Intervention group
Experimental group
Description:
The intervention group consisted of patients rehabilitated using the robotic platform.
Treatment:
Device: Robotic rehab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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