Effect of a Robotic Platform for Hip Fracture Rehab

Hip Fractures Clinical Trial

Official title:

Study of the Effect of Robotic Devices on the Functional Rehabilitation of Hip Fractures in Elderly People.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079555
• Other study ID #: SWalkerRehab
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: October 2021
• Source: Werium Assistive Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Device:
• Robotic rehab
Patients using the robotic platform SWalker

Locations

Country	Name	City	State
Spain	Albertia Servicios Sociosanitarios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Werium Assistive Solutions	Albertia Servicios Sociosanitarios

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of rehabilitation	Number of physiotherapy sessions	through study completion, an average of 3 months
Primary	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