Hip FracturesNCT06029361
Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device "SELFIT"
A study testing Selfit Device group in people with Hip Fractures, run by Meir Medical Center at 1 site in Israel.
Trial summary
Type of study: prospective interventional the purposes of the research :To examine the effect of treatment using the SELFIT system on function, walking and balance in patients after hip fractures hospitalized in the geriatric rehabilitation department. 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?
- Selfit Device group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Aug 2023to Jul 2024
- 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
- Ability to walk independently or under supervision before the fracture
- Patients with full weight bearing on the operated leg according to the instructions of an orthopedic surgeon (FWB - Full Weight Bearing)
- Patients who are able to walk with an assistive device FIM 3 and above (FIM Functional independence measure)
- Mental competence after a comprehensive assessment by a Geriatric Specialist
Who cannot join
- Patients with cognitive decline following dementia or delirium
- Patients with complications after surgery - infection or bleeding in the surgical area
- Patients with previous neurological injury or current CNS disease.
- Patients with a previous lower limb fracture in the last 5 years.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 4428163
Alexander Protsenko, M.Sc.PT, 972-9-7704326, alex.protsenko@clalit.org.il
About this study
Official title: Improving Function and Mobility in Geriatric Patients After a Femoral Neck Fracture Who Are Undergoing Inpatient Rehabilitation Using an Augmented Reality Practice System - SELFIT
Type of study: prospective interventional the purposes of the research :To examine the effect of treatment using the SELFIT system on function, walking and balance in patients after hip fractures hospitalized in the geriatric rehabilitation department.
The study population: 50 participants aged 65+ who were admitted to the geriatric rehabilitation department after hip fractures, with 25 in the experimental group and 25 in the control group.
Read more
The main question[s] it aims to answer are:
- What is the effect of training with SELFIT system on the functional outcomes in patients after hip fractures hospitalized in the geriatric rehabilitation department.
- How the training with SELFIT system will effect on satisfaction of the patients in the geriatric rehabilitation department.
During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.
Read the detailed description
Recruiting participants for the study:
When admitting patients hospitalized in the geriatric rehabilitation department after hip neck fractures, their suitability for participation in the study will be examined according to inclusion and exclusion criteria. Patients who meet the inclusion criteria will receive an explanation of the research procedure and its goals, and if they agree and are suitable in terms of signature competence and cognitive ability to participate in the study, they will sign an informed consent form for participation in the study.
After signing a consent form to participate in the study, each participant will be randomly assigned to an experimental group or a control group. After the patient agrees to participate in the study, he will receive a number that will be assigned in sequential order, where an even number means belonging to the experimental group and an odd number, belonging to the control group.
Intervention:
During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.
Both groups will receive physiotherapy treatment accepted in the geriatric rehabilitation department. Patients in both groups receive treatment that focuses on improving strength in the lower limbs, improving ROM, lying and standing exercises, walking with an assistive device according to the patient's ability.
In the second and third week of rehabilitation, patients progress to exercises to improve walking ability, which include standing practice to improve strength and balance, walking with an aid for distances according to the adjustment of walking ability, dynamic balance practice on unstable surfaces and practice on stairs.
Patients from the control group will receive standard treatment according to the patient's ability and the degrees of difficulty of the exercises will progress according to the ability of each patient. After the evaluation, the patients in the control group will receive an exercise in bed lying down or sitting to strengthen the lower limbs for about 15 minutes, an exercise in front of a bar to improve the strength of the lower limbs and the ability to stand up for about 15 minutes, an exercise to improve balance and walking for about 15 minutes.
Patients from the experimental group will receive exercise in bed lying down or sitting to strengthen lower limbs for about 15 minutes, exercise in front of a bar to improve lower limb strength and the ability to stand up for about 15 minutes, exercise in the SELFIT system of balance and walking for about 15 minutes. The intervention in the SELFIT system will be carried out 4 times a week by a physiotherapist in the department.
- Conditions
- Hip Fractures
- Being tested
- Selfit Device group, Control Group
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selfit Device groupDevice
During 21 days, intervention group will receive physical therapy of 45 minutes which 15 minutes out of the 45 minutes will be with the SELFIT system
Control GroupOther
Conventional physical therapy of 45 minute
| Study group | Role | What they receive |
|---|---|---|
| SELFIT device group | Experimental | 25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy Receives: Device: Selfit Device group |
| Control Group | Active comparator | 45 minutes of conventional physical therapy Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure
Measured by: Functional Independence Measure Index (FIM) that assess activity of daily living.
only motor assessment part is used. Minimum score 5 pts. Maximum score: 35 points.
Higher score means better outcome
Measured: 9 month
5 time sit to stand
Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome
Measured: 9 month
Berg Balance Test
Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.
Measured: 9 month
10 Meter walk test
Assessment of time performance of walking 10 meters. Less time means better outcome
Measured: 9 month
Falls Efficacy Scale
Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes
Measured: 9 month
VAS - visual analog scale
as mesured by a pain scale from 1 to 10. Lower score means better outcome
Measured: 9 month
PTPSQ-H physical therapy satisfaction questionnaire
Hebrew approved version. 15 questions about patient satisfaction with physical therapy care. Score range about 15 to 75.
Higher score means better outcomes
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start8 Aug 2023
- Primary completionMar 2024 (estimated)
- Study completionJul 2024 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Protsenko, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029361
- Sponsor's protocol ID
- 0003-22 MMC
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Function and Mobility in Geriatric Patients After a Femoral Neck Fracture Who Are Undergoing Inpatient Rehabilitation Using an Augmented Reality Practice System - SELFIT
- ClinicalTrials.gov ID
- NCT06029361
- Acronym / sponsor ID
- 0003-22 MMC
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 8 Sep 2023 (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.
Type of study: prospective interventional the purposes of the research :To examine the effect of treatment using the SELFIT system on function, walking and balance in patients after hip fractures hospitalized in the geriatric rehabilitation department.
The study population: 50 participants aged 65+ who were admitted to the geriatric rehabilitation department after hip fractures, with 25 in the experimental group and 25 in the control group.
The main question[s] it aims to answer are:
- What is the effect of training with SELFIT system on the functional outcomes in patients after hip fractures hospitalized in the geriatric rehabilitation department.
- How the training with SELFIT system will effect on satisfaction of the patients in the geriatric rehabilitation department.
During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.
Detailed description
Recruiting participants for the study:
When admitting patients hospitalized in the geriatric rehabilitation department after hip neck fractures, their suitability for participation in the study will be examined according to inclusion and exclusion criteria. Patients who meet the inclusion criteria will receive an explanation of the research procedure and its goals, and if they agree and are suitable in terms of signature competence and cognitive ability to participate in the study, they will sign an informed consent form for participation in the study.
After signing a consent form to participate in the study, each participant will be randomly assigned to an experimental group or a control group. After the patient agrees to participate in the study, he will receive a number that will be assigned in sequential order, where an even number means belonging to the experimental group and an odd number, belonging to the control group.
Intervention:
During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.
Both groups will receive physiotherapy treatment accepted in the geriatric rehabilitation department. Patients in both groups receive treatment that focuses on improving strength in the lower limbs, improving ROM, lying and standing exercises, walking with an assistive device according to the patient's ability.
In the second and third week of rehabilitation, patients progress to exercises to improve walking ability, which include standing practice to improve strength and balance, walking with an aid for distances according to the adjustment of walking ability, dynamic balance practice on unstable surfaces and practice on stairs.
Patients from the control group will receive standard treatment according to the patient's ability and the degrees of difficulty of the exercises will progress according to the ability of each patient. After the evaluation, the patients in the control group will receive an exercise in bed lying down or sitting to strengthen the lower limbs for about 15 minutes, an exercise in front of a bar to improve the strength of the lower limbs and the ability to stand up for about 15 minutes, an exercise to improve balance and walking for about 15 minutes.
Patients from the experimental group will receive exercise in bed lying down or sitting to strengthen lower limbs for about 15 minutes, exercise in front of a bar to improve lower limb strength and the ability to stand up for about 15 minutes, exercise in the SELFIT system of balance and walking for about 15 minutes. The intervention in the SELFIT system will be carried out 4 times a week by a physiotherapist in the department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SELFIT device group | Experimental | Device: Selfit Device group25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy |
| Control Group | Active comparator | Other: Control Group45 minutes of conventional physical therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Ability to walk independently or under supervision before the fracture
- Patients with full weight bearing on the operated leg according to the instructions of an orthopedic surgeon (FWB - Full Weight Bearing)
- Patients who are able to walk with an assistive device FIM 3 and above (FIM Functional independence measure)
- Mental competence after a comprehensive assessment by a Geriatric Specialist
Key exclusion criteria (4 listed)
- Patients with cognitive decline following dementia or delirium
- Patients with complications after surgery - infection or bleeding in the surgical area
- Patients with previous neurological injury or current CNS disease.
- Patients with a previous lower limb fracture in the last 5 years.
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 |
|---|---|---|
| Selfit Device groupDuring 21 days, intervention group will receive physical therapy of 45 minutes which 15 minutes out of the 45 minutes will be with the SELFIT system | Device | SELFIT device group |
| Control GroupConventional physical therapy of 45 minute | Other | Control Group |
Primary outcome
Functional Independence Measure
Time frame: 9 month
Measured by: Functional Independence Measure Index (FIM) that assess activity of daily living. only motor assessment part is used. Minimum score 5 pts. Maximum score: 35 points. Higher score means better outcome
5 time sit to stand
Time frame: 9 month
Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome
Berg Balance Test
Time frame: 9 month
Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.
10 Meter walk test
Time frame: 9 month
Assessment of time performance of walking 10 meters. Less time means better outcome
Falls Efficacy Scale
Time frame: 9 month
Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes
VAS - visual analog scale
Time frame: 9 month
as mesured by a pain scale from 1 to 10. Lower score means better outcome
PTPSQ-H physical therapy satisfaction questionnaire
Time frame: 9 month
Hebrew approved version. 15 questions about patient satisfaction with physical therapy care. Score range about 15 to 75. Higher score means better outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selfit Device group in people with Hip Fractures, run by Meir Medical Center at 1 site in Israel.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. 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 Israel. 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?
Results are not available in the source record.
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?
Functional Independence Measure (time frame: 9 month). The study lists 7 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 8 Sep 2023.