Balance Rehabilitation After Hip Fracture Surgery (BRS)

Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery

The overall functional gain by balance rehabilitation after hip fracture surgery has not yet been fully investigated. Therefore, clinical studies should be conducted to evaluate the effectiveness of systematic and safe balance rehabilitation in patients after hip fracture. Investigators aim to evaluate the effect of computer-based balance specific exercise on the performance and balance ability of the elderly women who underwent hip fracture surgery. Investigators also investigate the intervention can reduce their fear of falling and coping ability. This study was designed as a prospective, open-label, single-center trial at a tertiary hospital setting. During the 2-week postoperative intervention period, patients will participate in the hospital's exercise program beginning 5-7 days after hip fracture surgery. All participants will follow the computer-based balance specific exercise program. Functional outcomes will be measure periodically for 6 months after surgery.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Balance specific exercise

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Elderly female patients (≥ 65 years old) who have undergone surgery for femoral neck, intertrochanteric, or subtrochanteric fracture, regardless of surgery type (internal fixation, bipolar hemiarthroplasty, or total hip arthroplasty)

Exclusion Criteria:

• 1) hip surgery for infection, arthritis, implant loosening, or avascular necrosis;
• 2) femoral shaft fracture, acetabular fracture, isolated fracture of the greater or lesser tuberosity, or periprosthetic fracture;
• 3) pathologic fracture;
• 4) combined multiple fracture;
• 5) revision surgery;
• 6) severe cognitive dysfunction (obey command ≤ 1 step);
• 7) cannot stand by supporting a fixed walker at 5 days after operation;
• 8) patients who refuse to participate in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Balance exercise group; During the 2-week postoperative intervention period, patients will participate in the hospital's exercise program beginning 5-7 days after HFS. All participants will follow the computer-based balance specific exercise (BSE) program.

Procedure: Balance specific exercise; Balance specific exercise consists of total 10 days' physical therapy (PT) sessions (twice per day for 60 min) after surgery. It will be conducted with a computed posturographic system for diagnostics of balance and movement skills (Balance Master® System NeuroCom®) designed to objectively quantify balance and postural function of different origin. PT (weight-bearing, strengthening, gait training, aerobic, and functional exercises) was gradually increased based on the patient's functional level. Intensive patient education by multidisciplinary rehabilitation members was also provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Berg balance scale	Berg balance scale (total score; 0 to 56)	Change from Baseline Berg balance scale at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulatory Category	Functional Ambulatory Category (categorical score; 0 to 5)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Functional Independence Measure: locomotion	Functional Independence Measure (subscale of locomotion: 1 to 7)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Modified falls efficacy scale	Modified falls efficacy scale (total score: 0 to 140)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Presence of Fear of falling	Fear of falling (yes or no; by simple question "Are you afraid of falling?")	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Modified Barthel index	Modified Barthel index (tota; score: 0 to 100)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Short physical performance scale	Short physical performance scale (total score: 0 to 12)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 20-2018-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No