Balance Rehabilitation After Hip Fracture Surgery

Hip Fractures Clinical Trial

— BRS  

Official title:

Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03618576
• Other study ID #: 20-2018-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Berg balance scale	Berg balance scale (total score; 0 to 56)	Change from Baseline Berg balance scale at 6 months
Secondary	Functional Ambulatory Category	Functional Ambulatory Category (categorical score; 0 to 5)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Modified Barthel index	Modified Barthel index (tota; score: 0 to 100)	Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Secondary	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