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Status unknownNCT06029361Updated Sep 8, 2023

Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device "SELFIT"

An interventional study of Selfit Device group and Control Group in Hip Fractures, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Meir Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Hip Fractures

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03

In context

Hip Fractures

848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 540 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 400 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    SELFIT device group

    25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy

    Device: Selfit Device group

  • Active comparator
    Control Group

    45 minutes of conventional physical therapy

    Other: Control Group

Interventions

  • DeviceSelfit Device group

    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

  • OtherControl Group

    Conventional physical therapy of 45 minute

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 month

  2. 5 time sit to stand

    Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome

    Time frame: 9 month

  3. Berg Balance Test

    Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.

    Time frame: 9 month

  4. 10 Meter walk test

    Assessment of time performance of walking 10 meters. Less time means better outcome

    Time frame: 9 month

  5. Falls Efficacy Scale

    Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes

    Time frame: 9 month

  6. VAS - visual analog scale

    as mesured by a pain scale from 1 to 10. Lower score means better outcome

    Time frame: 9 month

  7. 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

    Time frame: 9 month

07

Study locations

1 of 1 sites recruiting
  • Meir Medical Center
    Kfar Saba, 4428163, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06029361
Responsible party
Alexander Protsenko (Head of physiotherapy of geriatric rehabilitation unit, Meir Medical Center) — Principal investigator
First posted
Sep 8, 2023
Start date
Aug 8, 2023
Primary completion
Mar 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Sep 8, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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