Hip Fractures Clinical Trial
Official title:
Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
The final goals of the present study is to propose a new approach in the hip fracture rehabilitation in elderly subjects, focused on the use of robotic device and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.
Status | Recruiting |
Enrollment | 195 |
Est. completion date | March 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Capacity to consent - Traumatic event within 60 days - Romberg test: negative - Functional Ambulation Category (FAC) score = 2 - Ranking scale score = 3; Exclusion Criteria: - Past history of syncopal episodes - Presence of non-pharmacologically compensated behavioral syndromes - Presence of pain that prevents walking or standing - Presence of neurological pathologies that compromise balance (Multiple sclerosis, Parkinson's disease, stroke, ataxias, poliomyelitis) - Spinal stenosis - Radiculopathy - Neuropathies lower limbs - Disabling disabilities that impair walking (eg congenital malformations of the foot) - Heterometry > 2 cm - Clinical dementia rating (CDR) score = 3 - Severe systemic diseases with life expectancy < 1 year - Patients unable to follow up. |
Country | Name | City | State |
---|---|---|---|
Italy | INRCA Research Hospital | Ancona | |
Italy | INRCA Research Hospital | Fermo |
Lead Sponsor | Collaborator |
---|---|
Istituto Nazionale di Ricovero e Cura per Anziani |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm | falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score < 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk | before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement | |
Secondary | difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm | gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis | before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement | |
Secondary | difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm | fear of falling will be evaluated by the Falls Efficacy Scale - International (FES-I). Higher scores represent greater the fear of falling (ranging from 16 to 64) | before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02507609 -
Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium
|
N/A | |
Completed |
NCT03906864 -
Care Pathway for Sub-acute Hip Rehabilitation
|
N/A | |
Recruiting |
NCT04063891 -
Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients
|
N/A | |
Completed |
NCT05039879 -
Life Improving Factors After a Hip Fracture
|
||
Not yet recruiting |
NCT03887494 -
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)
|
N/A | |
Terminated |
NCT03065101 -
Trigen InterTAN vs Sliding Hip Screw RCT
|
N/A | |
Completed |
NCT03545347 -
Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.
|
Phase 2 | |
Completed |
NCT03695081 -
Patient Pathway Pharmacist - Optimal Drug-related Care
|
N/A | |
Recruiting |
NCT05971173 -
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
|
Early Phase 1 | |
Active, not recruiting |
NCT04957251 -
Anterior vs Posterior Approach for Hip Hemiarthroplasty
|
N/A | |
Terminated |
NCT04372966 -
Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures
|
N/A | |
Withdrawn |
NCT05030688 -
Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty
|
N/A | |
Completed |
NCT04424186 -
'Rehabilitation for Life'
|
N/A | |
Not yet recruiting |
NCT04183075 -
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
|
N/A | |
Withdrawn |
NCT05518279 -
Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures
|
Phase 3 | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
Active, not recruiting |
NCT02247791 -
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT00746876 -
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
|
N/A | |
Completed |
NCT00058864 -
The HIP Impact Protection Program (HIP PRO)
|
N/A |