Balance Rehabilitation After Hip Fracture Surgery

Not Applicable

• Conditions: Hip Fractures
• Interventions: Procedure: Balance specific exercise

• Registration Number: NCT03618576
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-19
• Status Verified: 2018-08
• Study Start: 2018-08
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-07
• Last Update Posted: 2018-08-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balance exercise group	Balance specific exercise	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.

Primary Outcome Measures

Name	Time	Method
Change of Berg balance scale	Change from Baseline Berg balance scale at 6 months	Berg balance scale (total score; 0 to 56)

Secondary Outcome Measures

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