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Balance Rehabilitation After Hip Fracture Surgery (BRS)

Primary Purpose

Hip Fractures

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Balance specific exercise

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - 100 Years (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Balance exercise group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of Berg balance scale

Berg balance scale (total score; 0 to 56)

Secondary Outcome Measures

Functional Ambulatory Category

Functional Ambulatory Category (categorical score; 0 to 5)

Functional Independence Measure: locomotion

Functional Independence Measure (subscale of locomotion: 1 to 7)

Modified falls efficacy scale

Modified falls efficacy scale (total score: 0 to 140)

Presence of Fear of falling

Fear of falling (yes or no; by simple question "Are you afraid of falling?")

Modified Barthel index

Modified Barthel index (tota; score: 0 to 100)

Short physical performance scale

Short physical performance scale (total score: 0 to 12)

Full Information

NCT ID

NCT03618576

First Posted

July 19, 2018

Last Updated

August 1, 2018

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03618576

Brief Title

Balance Rehabilitation After Hip Fracture Surgery

Acronym

BRS

Official Title

Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2018 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Balance exercise group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Balance specific exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of Berg balance scale

Description

Berg balance scale (total score; 0 to 56)

Time Frame

Change from Baseline Berg balance scale at 6 months

Secondary Outcome Measure Information:

Title

Functional Ambulatory Category

Description

Functional Ambulatory Category (categorical score; 0 to 5)

Time Frame