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

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Selfit Device group
Control Group
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SELFIT device group

Control Group

Arm Description

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

45 minutes of conventional physical therapy

Outcomes

Primary Outcome Measures

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
5 time sit to stand
Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome
Berg Balance Test
Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.
10 Meter walk test
Assessment of time performance of walking 10 meters. Less time means better outcome
Falls Efficacy Scale
Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes
VAS - visual analog scale
as mesured by a pain scale from 1 to 10. Lower score means better outcome
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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
August 31, 2023
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06029361
Brief Title
Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device "SELFIT"
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
an assessment will be made by questionnaires and an objective assessment by physiotherapists who will not be involved in the treatment of the SELFIT system in the interventional group
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SELFIT device group
Arm Type
Experimental
Arm Description
25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
45 minutes of conventional physical therapy
Intervention Type
Device
Intervention Name(s)
Selfit Device group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Conventional physical therapy of 45 minute
Primary Outcome Measure Information:
Title
Functional Independence Measure
Description
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
Title
5 time sit to stand
Description
Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome
Time Frame
9 month
Title
Berg Balance Test
Description
Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.
Time Frame
9 month
Title
10 Meter walk test
Description
Assessment of time performance of walking 10 meters. Less time means better outcome
Time Frame
9 month
Title
Falls Efficacy Scale
Description
Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes
Time Frame
9 month
Title
VAS - visual analog scale
Description
as mesured by a pain scale from 1 to 10. Lower score means better outcome
Time Frame
9 month
Title
PTPSQ-H physical therapy satisfaction questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
Meir Medical Center
City
Kfar saba
ZIP/Postal Code
4428163
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Protsenko, M.Sc.PT
Phone
972-9-7704326
Email
alex.protsenko@clalit.org.il

12. IPD Sharing Statement

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

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