Fracture FemurFEWFNCT07392515
Cognitive and Physical Recovery After Hip Fracture in Frail Patients Using Digital Rehabilitation Technology
A study testing Experimental intervention - integrated treatment with a sensor-based device and Conventional rehabilitation intervention in people with Fracture Femur and Hip Arthroplasty Replacement, run by C.O.T. Cure Ortopediche Traumatologiche S.p.A. at 2 sites in Italy.
Trial summary
The aim of this study is to evaluate whether integrating a technology-based rehabilitation approach with conventional therapies in the rehabilitation of patients with proximal femoral fracture may be advantageous compared with conventional therapy alone. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Fracture Femur, Hip Arthroplasty Replacement, Total Hip Arthroplasty (THA)
- What is being tested?
- Experimental intervention - integrated treatment with a sensor-based device and Conventional rehabilitation intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age between 65 and 89 years
- Patients who have undergone one of the following surgical treatments specifically for proximal femur fracture including Total hip arthroplasty (total hip replacement), Partial hip arthroplasty (hemiarthroplasty), Intramedullary nailing
- Time since surgery not exceeding 15 days
- Clinical stability
- Patients admitted to the rehabilitation wards of the centers involved in the study and therefore eligible for rehabilitative therapy.
Who cannot join
- Age > 90 years
- Age < 65 years
- Refusal to sign the informed consent form
- Behavioral or cognitive disorders limiting compliance with the rehabilitative treatment
- Presence of mechanical instability of the implanted surgical device
- Clinical instability (e.g., sepsis, severe anemia, cardiorespiratory failure) or pre-existing comorbidities affecting ambulation (neurological diseases or chronic pre-existing disabilities)
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- Concomitant presence of other fractures that prevent the possibility of carrying out a rehabilitative treatment
- Severe visual impairments not correctable with lenses that prevent the patient from performing the treatment using digital tools
- Pre-existing motor disability prior to the femur fracture due to other systemic diseases (e.g., advanced-stage neurodegenerative diseases, severe heart failure)
- Conditions contraindicating the use of sensors (pacemaker, epilepsy, skin lesions, open wounds, and severe allergies in areas of contact with the devices).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
COT - Cure Ortopediche Traumatologiche
Messina, Italy, 98124
Ennio Ferlazzo, MD, 39 090 6601, innovazione@hrcot.com
- Not yet recruiting
Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza
Roma, Italy, 00166
Irene G Aprile, MD, PhD, 00390633086500, iaprile@dongnocchi.it
About this study
Official title: Cognitive and Motor Recovery in Frail Patients With Hip Fracture: Effectiveness of Digital Technology-Assisted Rehabilitation and Analysis of Biomolecular Mechanisms
The aim of this study is to evaluate whether integrating a technology-based rehabilitation approach with conventional therapies in the rehabilitation of patients with proximal femoral fracture may be advantageous compared with conventional therapy alone. Specifically, the objective is to assess whether the addition of technology-assisted rehabilitation can improve cognitive function, in addition to motor function and overall abilities, compared with conventional rehabilitation alone. Furthermore, the study intends to explore the feasibility of implementing technology-assisted rehabilitation as a stable and routine component of everyday clinical practice, also considering the perspective of healthcare professionals.
Read the detailed description
This is a national, multicenter, non-profit, post-market interventional longitudinal clinical study designed to evaluate the effectiveness of integrating technology-assisted rehabilitation with conventional rehabilitation in elderly patients undergoing inpatient rehabilitation after surgically treated proximal femoral fracture.
Eligible participants aged 65 to 89 years who have undergone surgical treatment for proximal femoral fracture (total hip arthroplasty, partial hip arthroplasty, or intramedullary nailing) and who are clinically stable will be enrolled during their inpatient rehabilitation stay. After enrollment, patients will be randomly assigned to one of two treatment arms: (1) conventional rehabilitation alone (control group) or (2) integrated rehabilitation combining conventional therapy with sensor-based technology-assisted rehabilitation (experimental group). Randomization will be centralized and stratified by center and age group.
The total rehabilitation program consists of 18 sessions delivered over approximately 3-4 weeks, with a frequency of 5-6 sessions per week. Patients in the experimental group will perform approximately one-third of daily rehabilitation sessions using sensor-based digital devices providing real-time visual and auditory feedback, and two-thirds with conventional rehabilitation. Technology-assisted training includes facilitated active joint mobilization, motor and cognitive stimulation tasks, and gait training. The control group will receive conventional rehabilitation only, including assisted joint mobilization, postural re-education, muscle strengthening exercises, and gait training with assistive devices.
Clinical assessments will be performed at baseline (T0) and at the end of the rehabilitation program (T1). Motor performance will be assessed using the Timed Up and Go (TUG) test, which measures the time required for a participant to stand up from a chair, walk three meters, turn around, walk back, and sit down, as well as the Timed Up and Go Dual Task (TUG Dual Task), which evaluates mobility under simultaneous cognitive or motor task conditions. Additional functional outcomes include the Harris Hip Score, Barthel Index, pain assessed by Numeric Rating Scale, and health-related quality of life assessed by the SF-36. Cognitive status will be assessed using the Mini-Mental State Examination (MMSE). Blood samples will be collected at T0 and T1 to measure serum brain-derived neurotrophic factor (BDNF) levels and to analyze the rs6265 (Val66Met) polymorphism.
The primary endpoints are the change in serum BDNF levels and the change in TUG and TUG Dual Task performance from baseline to the end of treatment. Secondary endpoints include changes in functional scores, pain, quality of life, and exploratory analysis of the BDNF genetic polymorphism.
Healthcare professionals involved in the rehabilitation program will also complete the Work-Related Quality of Life (WRQoL) questionnaire to explore the perceived impact of technology-assisted rehabilitation on work-related quality of life.
Statistical analysis will be performed to evaluate differences between the control and experimental groups and changes over time in outcome measures. A p-value < 0.05 will be considered statistically significant.
- Being tested
- Experimental intervention - integrated treatment with a sensor-based device, Conventional rehabilitation intervention
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental intervention - integrated treatment with a sensor-based deviceDevice
The technology/robotic group will perform one-third (1/3) of the daily rehabilitation using technology-assisted devices and two-thirds (2/3) using conventional rehabilitation. In addition to the conventional rehabilitation described below, the treatment will include technology-assisted rehabilitation consisting of facilitated active joint mobilization exercises with visual and auditory feedback, aimed at stimulating motor and cognitive functions, as well as gait training.
Conventional rehabilitation interventionOther
The conventional rehabilitation programme includes assisted and facilitated joint mobilization exercises to improve range of motion; exercises for postural readaptation of the trunk to the upright position; isometric exercises; and gait training using a 4-wheeled walker or forearm crutches (Canadian crutches), aimed at improving walking ability and achieving an appropriate recovery of the gait pattern.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Patients receive a standard inpatient conventional rehabilitation program including joint mobilization, postural re-education, muscle strengthening, and gait training with assistive devices. Receives: Other: Conventional rehabilitation intervention |
| Technology-Assisted Integrated Rehabilitation | Experimental | Patients receive an integrated rehabilitation program combining sensor-based technology-assisted training (1/3 of daily sessions) with conventional rehabilitation (2/3 of daily sessions). Receives: Device: Experimental intervention - integrated treatment with a sensor-based device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum BDNF levels
Difference in serum brain-derived neurotrophic factor (BDNF) levels between baseline and the end of the rehabilitative treatment, assessed to evaluate biomolecular changes associated with neuroplasticity.
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Change in Timed Up and Go test
Difference in functional mobility, balance, and gait performance assessed using the Timed Up and Go test between baseline and end of rehabilitative treatment.
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Change in Timed Up and Go Dual Task test
Difference in cognitive-motor dual-task performance assessed using the Timed Up and Go Dual Task test between baseline and end of rehabilitative treatment.
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Secondary outcomes (6)
Change in the Harris Hip Score (HHS)
Change in hip function, pain, and functional ability as assessed by the Harris Hip Score, a clinician-administered outcome measure ranging from 0 to 100 points, where higher scores indicate better hip function, assessed at baseline and at the end of the rehabilitative treatment.
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Change in the modified Barthel Index
Change in independence in activities of daily living as assessed by item-level scores of the Barthel Index, a validated measure of functional independence ranging from 0 to 100 points, where higher scores indicate greater independence, assessed at baseline and at the end of the rehabilitative treatment (Italian version, 2015).
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Change in pain intensity measured by the Numeric Rating Scale (NRS)
Change in pain intensity as assessed by the Numeric Rating Scale, a patient-reported outcome measure ranging from 0 to 10, where higher scores indicate greater pain intensity, assessed at baseline and at the end of the rehabilitative treatment.
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Change in quality of life measured by the SF-36
Change in health-related quality of life as assessed by the 36-Item Short Form Health Survey (SF-36), a validated patient-reported outcome measure composed of multiple domains, each scored on a 0 to 100 scale, where higher scores indicate better health-related quality of life, assessed at baseline and at the end of the rehabilitative treatment.
Measured: Baseline and within 3 days after completion of the rehabilitative treatment
Analysis of the rs6265 polymorphism (Val66Met mutation) of the BDNF gen
Genotyping of the BDNF rs6265 (Val66Met; G196A) single-nucleotide polymorphism to classify participants as Val/Val, Val/Met, or Met/Met and explore its association with serum BDNF levels and rehabilitative outcomes.
Measured: Baseline
Healthcare professionals' perspective on work-related quality of work in the two different treatment approaches.
Assessment of healthcare professionals' work-related quality of life using the Work-Related Quality of Life Scale (WRQoL).
The WRQoL total score ranges from 23 to 115, with higher scores indicating better perceived work-related quality of life.
Measured: At the end of treatment delivery for both interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start9 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture FemurStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C.O.T. Cure Ortopediche Traumatologiche S.p.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Principal investigator, Ennio Ferlazzo, C.O.T. Cure Ortopediche Traumatologiche S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392515
- Sponsor's protocol ID
- PNC0000007-B53C22006770008
- Acronym
- FEWF
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Motor Recovery in Frail Patients With Hip Fracture: Effectiveness of Digital Technology-Assisted Rehabilitation and Analysis of Biomolecular Mechanisms
- ClinicalTrials.gov ID
- NCT07392515
- Acronym / sponsor ID
- FEWF / PNC0000007-B53C22006770008
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- C.O.T. Cure Ortopediche Traumatologiche S.p.A.University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
The aim of this study is to evaluate whether integrating a technology-based rehabilitation approach with conventional therapies in the rehabilitation of patients with proximal femoral fracture may be advantageous compared with conventional therapy alone. Specifically, the objective is to assess whether the addition of technology-assisted rehabilitation can improve cognitive function, in addition to motor function and overall abilities, compared with conventional rehabilitation alone. Furthermore, the study intends to explore the feasibility of implementing technology-assisted rehabilitation as a stable and routine component of everyday clinical practice, also considering the perspective of healthcare professionals.
Detailed description
This is a national, multicenter, non-profit, post-market interventional longitudinal clinical study designed to evaluate the effectiveness of integrating technology-assisted rehabilitation with conventional rehabilitation in elderly patients undergoing inpatient rehabilitation after surgically treated proximal femoral fracture.
Eligible participants aged 65 to 89 years who have undergone surgical treatment for proximal femoral fracture (total hip arthroplasty, partial hip arthroplasty, or intramedullary nailing) and who are clinically stable will be enrolled during their inpatient rehabilitation stay. After enrollment, patients will be randomly assigned to one of two treatment arms: (1) conventional rehabilitation alone (control group) or (2) integrated rehabilitation combining conventional therapy with sensor-based technology-assisted rehabilitation (experimental group). Randomization will be centralized and stratified by center and age group.
The total rehabilitation program consists of 18 sessions delivered over approximately 3-4 weeks, with a frequency of 5-6 sessions per week. Patients in the experimental group will perform approximately one-third of daily rehabilitation sessions using sensor-based digital devices providing real-time visual and auditory feedback, and two-thirds with conventional rehabilitation. Technology-assisted training includes facilitated active joint mobilization, motor and cognitive stimulation tasks, and gait training. The control group will receive conventional rehabilitation only, including assisted joint mobilization, postural re-education, muscle strengthening exercises, and gait training with assistive devices.
Clinical assessments will be performed at baseline (T0) and at the end of the rehabilitation program (T1). Motor performance will be assessed using the Timed Up and Go (TUG) test, which measures the time required for a participant to stand up from a chair, walk three meters, turn around, walk back, and sit down, as well as the Timed Up and Go Dual Task (TUG Dual Task), which evaluates mobility under simultaneous cognitive or motor task conditions. Additional functional outcomes include the Harris Hip Score, Barthel Index, pain assessed by Numeric Rating Scale, and health-related quality of life assessed by the SF-36. Cognitive status will be assessed using the Mini-Mental State Examination (MMSE). Blood samples will be collected at T0 and T1 to measure serum brain-derived neurotrophic factor (BDNF) levels and to analyze the rs6265 (Val66Met) polymorphism.
The primary endpoints are the change in serum BDNF levels and the change in TUG and TUG Dual Task performance from baseline to the end of treatment. Secondary endpoints include changes in functional scores, pain, quality of life, and exploratory analysis of the BDNF genetic polymorphism.
Healthcare professionals involved in the rehabilitation program will also complete the Work-Related Quality of Life (WRQoL) questionnaire to explore the perceived impact of technology-assisted rehabilitation on work-related quality of life.
Statistical analysis will be performed to evaluate differences between the control and experimental groups and changes over time in outcome measures. A p-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Other: Conventional rehabilitation interventionPatients receive a standard inpatient conventional rehabilitation program including joint mobilization, postural re-education, muscle strengthening, and gait training with assistive devices. |
| Technology-Assisted Integrated Rehabilitation | Experimental | Device: Experimental intervention - integrated treatment with a sensor-based devicePatients receive an integrated rehabilitation program combining sensor-based technology-assisted training (1/3 of daily sessions) with conventional rehabilitation (2/3 of daily sessions). |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age between 65 and 89 years
- Patients who have undergone one of the following surgical treatments specifically for proximal femur fracture including Total hip arthroplasty (total hip replacement), Partial hip arthroplasty (hemiarthroplasty), Intramedullary nailing
- Time since surgery not exceeding 15 days
- Clinical stability
- Patients admitted to the rehabilitation wards of the centers involved in the study and therefore eligible for rehabilitative therapy.
Key exclusion criteria (10 listed)
- Age > 90 years
- Age < 65 years
- Refusal to sign the informed consent form
- Behavioral or cognitive disorders limiting compliance with the rehabilitative treatment
- Presence of mechanical instability of the implanted surgical device
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 |
|---|---|---|
| Experimental intervention - integrated treatment with a sensor-based deviceThe technology/robotic group will perform one-third (1/3) of the daily rehabilitation using technology-assisted devices and two-thirds (2/3) using conventional rehabilitation. In addition to the conventional rehabilitation described below, the treatment will include technology-assisted rehabilitation consisting of facilitated active joint mobilization exercises with visual and auditory feedback, aimed at stimulating motor and cognitive functions, as well as gait training. | Device | Technology-Assisted Integrated Rehabilitation |
| Conventional rehabilitation interventionThe conventional rehabilitation programme includes assisted and facilitated joint mobilization exercises to improve range of motion; exercises for postural readaptation of the trunk to the upright position; isometric exercises; and gait training using a 4-wheeled walker or forearm crutches (Canadian crutches), aimed at improving walking ability and achieving an appropriate recovery of the gait pattern. | Other | Conventional Rehabilitation |
Primary outcome
Changes in serum BDNF levels
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Difference in serum brain-derived neurotrophic factor (BDNF) levels between baseline and the end of the rehabilitative treatment, assessed to evaluate biomolecular changes associated with neuroplasticity.
Change in Timed Up and Go test
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Difference in functional mobility, balance, and gait performance assessed using the Timed Up and Go test between baseline and end of rehabilitative treatment.
Change in Timed Up and Go Dual Task test
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Difference in cognitive-motor dual-task performance assessed using the Timed Up and Go Dual Task test between baseline and end of rehabilitative treatment.
6 secondary outcomes
Change in the Harris Hip Score (HHS)
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Change in the modified Barthel Index
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Change in pain intensity measured by the Numeric Rating Scale (NRS)
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Change in quality of life measured by the SF-36
Time frame: Baseline and within 3 days after completion of the rehabilitative treatment
Analysis of the rs6265 polymorphism (Val66Met mutation) of the BDNF gen
Time frame: Baseline
Healthcare professionals' perspective on work-related quality of work in the two different treatment approaches.
Time frame: At the end of treatment delivery for both interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- 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.
Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza
Roma, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental intervention - integrated treatment with a sensor-based device and Conventional rehabilitation intervention in people with Fracture Femur and Hip Arthroplasty Replacement, run by C.O.T. Cure Ortopediche Traumatologiche S.p.A. at 2 sites in Italy.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum BDNF levels (time frame: Baseline and within 3 days after completion of the rehabilitative treatment). The study lists 3 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 13 Mar 2026.