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Balance Rehabilitation After Hip Fracture Surgery (BRS)

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ClinicalTrials.gov Identifier: NCT03618576
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Yoon Lee, 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.

Condition or disease Intervention/treatment Phase
Hip Fractures Procedure: Balance specific exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Balance exercise group
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
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 Measures :
  1. Change of Berg balance scale [ Time Frame: Change from Baseline Berg balance scale at 6 months ]
    Berg balance scale (total score; 0 to 56)


Secondary Outcome Measures :
  1. Functional Ambulatory Category [ Time Frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery ]
    Functional Ambulatory Category (categorical score; 0 to 5)

  2. Functional Independence Measure: locomotion [ Time Frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery ]
    Functional Independence Measure (subscale of locomotion: 1 to 7)

  3. Modified falls efficacy scale [ Time Frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery ]
    Modified falls efficacy scale (total score: 0 to 140)

  4. Presence of Fear of falling [ Time Frame: 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?")

  5. Modified Barthel index [ Time Frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery ]
    Modified Barthel index (tota; score: 0 to 100)

  6. Short physical performance scale [ Time Frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery ]
    Short physical performance scale (total score: 0 to 12)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Sang Yoon Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03618576     History of Changes
Other Study ID Numbers: 20-2018-46
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries