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Effect of a Robotic Platform for Hip Fracture Rehab

NCT ID: NCT05079555

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-04-15

Brief Summary

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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

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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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

The control group consisted of patients who followed conventional therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

Robotic rehab

Intervention Type DEVICE

Patients using the robotic platform SWalker

Interventions

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Robotic rehab

Patients using the robotic platform SWalker

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albertia Servicios Sociosanitarios

UNKNOWN

Sponsor Role collaborator

Werium Assistive Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Vanina Costa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Albertia Servicios Sociosanitarios

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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SWalkerRehab

Identifier Type: -

Identifier Source: org_study_id