Effect of a Robotic Platform for Hip Fracture Rehab

NCT05079555 | Completed

• 1 other identifier: SWalkerRehab
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

• effectiveness of rehabilitation

  Number of physiotherapy sessions

  through study completion, an average of 3 months

• Degree of gait recovery

  time to recovery of autonomous walking to perform their daily functional tasks (days)

  through study completion, an average of 3 months

Study Arms (2)

Control group

NO INTERVENTION

The control group consisted of patients who followed conventional therapy.

Intervention group

EXPERIMENTAL

The intervention group consisted of patients rehabilitated using the robotic platform.

Device: Robotic rehab

Interventions

Robotic rehab DEVICE

Patients using the robotic platform SWalker

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Werium Assistive Solutions: lead
• Albertia Servicios Sociosanitarios: collaborator

Study Sites (1)

Albertia Servicios Sociosanitarios

Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. 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.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 15, 2021
• Study Start: March 1, 2018
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)