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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03618576
Other study ID # 20-2018-46
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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