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

NCT06029361 | Unknown DMC

• 1 other identifier: 0003-22 MMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (7)

• 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

  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

  9 month

• Berg Balance Test

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

  9 month

• 10 Meter walk test

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

  9 month

• Falls Efficacy Scale

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

  9 month

• VAS - visual analog scale

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

  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

  9 month

Study Arms (2)

SELFIT device group

EXPERIMENTAL

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

Device: Selfit Device group

Control Group

ACTIVE COMPARATOR

45 minutes of conventional physical therapy

Other: Control Group

Interventions

Selfit Device group 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

SELFIT device group

Control Group OTHER

Conventional physical therapy of 45 minute

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 4428163, Israel

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of physiotherapy of geriatric rehabilitation unit

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 8, 2023
• Study Start: August 8, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-08

Locations

IL (1)