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Effect of a Robotic Platform for Hip Fracture Rehab

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Robotic rehab
Sponsored by
Werium Assistive Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Albertia Servicios Sociosanitarios

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

The control group consisted of patients who followed conventional therapy.

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

Outcomes

Primary Outcome Measures

effectiveness of rehabilitation
Number of physiotherapy sessions
Degree of gait recovery
time to recovery of autonomous walking to perform their daily functional tasks (days)

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
October 3, 2021
Sponsor
Werium Assistive Solutions
Collaborators
Albertia Servicios Sociosanitarios
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1. Study Identification

Unique Protocol Identification Number
NCT05079555
Brief Title
Effect of a Robotic Platform for Hip Fracture Rehab
Official Title
Study of the Effect of Robotic Devices on the Functional Rehabilitation of Hip Fractures in Elderly People.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Werium Assistive Solutions
Collaborators
Albertia Servicios Sociosanitarios

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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. 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group consisted of patients who followed conventional therapy.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group consisted of patients rehabilitated using the robotic platform.
Intervention Type
Device
Intervention Name(s)
Robotic rehab
Intervention Description
Patients using the robotic platform SWalker
Primary Outcome Measure Information:
Title
effectiveness of rehabilitation
Description
Number of physiotherapy sessions
Time Frame
through study completion, an average of 3 months
Title
Degree of gait recovery
Description
time to recovery of autonomous walking to perform their daily functional tasks (days)
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Albertia Servicios Sociosanitarios
City
Madrid
ZIP/Postal Code
28222
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of a Robotic Platform for Hip Fracture Rehab

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