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.

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Device: Robotic rehab

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28222
    • Albertia Servicios Sociosanitarios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; The control group consisted of patients who followed conventional therapy.
EXPERIMENTAL: Intervention group; The intervention group consisted of patients rehabilitated using the robotic platform.	Device: Robotic rehab; Patients using the robotic platform SWalker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Werium Assistive Solutions
• Collaborators: Albertia Servicios Sociosanitarios

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): April 15, 2020
• Study Completion (ACTUAL): April 15, 2020

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 3, 2021
• First Posted (ACTUAL): October 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: SWalkerRehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No