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OpenTrials
Completed

NCT Number: NCT05079555

Effect of a Robotic Platform for Hip Fracture Rehab

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albertia Servicios Sociosanitarios

Madrid, 28222, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic rehab

Device

Patients using the robotic platform SWalker

Primary outcomes

  1. effectiveness of rehabilitation

    Time frame: through study completion, an average of 3 months

    Number of physiotherapy sessions

  2. Degree of gait recovery

    Time frame: through study completion, an average of 3 months

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

Sponsors and collaborators

Lead sponsor

Werium Assistive Solutions

Industry

Collaborators

  • Albertia Servicios Sociosanitarios

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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