Balance Rehabilitation After Hip Fracture Surgery

NCT03618576 | Unknown DMC

• 1 other identifier: 20-2018-46
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Change of Berg balance scale

  Berg balance scale (total score; 0 to 56)

  Change from Baseline Berg balance scale at 6 months

Secondary Outcomes (6)

• Functional Ambulatory Category

  Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

• Functional Independence Measure: locomotion

  Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

• Modified falls efficacy scale

  Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

• Presence of Fear of falling

  Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

• Modified Barthel index

  Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

Study Arms (1)

Balance exercise group

EXPERIMENTAL

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

Interventions

Balance specific exercise PROCEDURE

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.

Balance exercise group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 7, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share