Hip FracturesNCT05079555
Effect of a Robotic Platform for Hip Fracture Rehab
A study testing Robotic rehab in people with Hip Fractures, run by Werium Assistive Solutions at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Robotic rehab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who, after recently having undergone a hip fracture surgery, needed subsequent rehabilitation to restore autonomous ambulation
- patients over 65 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Robotic rehab
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic rehabDevice
Patients using the robotic platform SWalker
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group consisted of patients who followed conventional therapy. |
| Intervention group | Experimental | The intervention group consisted of patients rehabilitated using the robotic platform. Receives: Device: Robotic rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of rehabilitation
Number of physiotherapy sessions
Measured: 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)
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Mar 2018
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Werium Assistive Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Albertia Servicios Sociosanitarios
- Responsible party
- Principal investigator, Vanina Costa, Werium Assistive Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079555
- Sponsor's protocol ID
- SWalkerRehab
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Robotic Devices on the Functional Rehabilitation of Hip Fractures in Elderly People.
- ClinicalTrials.gov ID
- NCT05079555
- Acronym / sponsor ID
- SWalkerRehab
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Werium Assistive SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Albertia Servicios Sociosanitarios
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group consisted of patients who followed conventional therapy. |
| Intervention group | Experimental | Device: Robotic rehabThe intervention group consisted of patients rehabilitated using the robotic platform. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients who, after recently having undergone a hip fracture surgery, needed subsequent rehabilitation to restore autonomous ambulation
- patients over 65 years of age
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic rehabPatients using the robotic platform SWalker | Device | Intervention group |
Primary outcome
effectiveness of rehabilitation
Time frame: through study completion, an average of 3 months
Number of physiotherapy sessions
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic rehab in people with Hip Fractures, run by Werium Assistive Solutions at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of rehabilitation (time frame: through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.