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

NCT ID: NCT06029361

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2024-07-31

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SELFIT device group

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

Group Type: EXPERIMENTAL

Selfit Device group

Intervention Type: DEVICE

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 Group

45 minutes of conventional physical therapy

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Conventional physical therapy of 45 minute

Interventions

Selfit 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

Intervention Type: DEVICE

Control Group

Conventional physical therapy of 45 minute

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alexander Protsenko

Head of physiotherapy of geriatric rehabilitation unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Alexander Protsenko, M.Sc.PT

Role: primary

alex.protsenko@clalit.org.il

972-9-7704326

Other Identifiers

0003-22 MMC

Identifier Type: -

Identifier Source: org_study_id