Hip FracturesBRSNCT03618576

Balance Rehabilitation After Hip Fracture Surgery

A study testing Balance specific exercise in people with Hip Fractures, run by Seoul National University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 65 to 100 years, women only
Conditions the study is for: Hip Fractures
What is being tested?: Balance specific exercise
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: Aug 2018to Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 100 years
Women only
No healthy volunteers
Older adult

Who may be able to join

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)

Who cannot join

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

About this study

Official title: Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery

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
Being tested: Balance specific exercise
Medical subject headings: Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Balance specific exerciseProcedure or surgery
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.

Study groups in NCT03618576
Study group	Role	What they receive
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. Receives: Procedure: Balance specific exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Berg balance scale
Berg balance scale (total score; 0 to 56)
Measured: Change from Baseline Berg balance scale at 6 months

Secondary outcomes (6)

Functional Ambulatory Category
Functional Ambulatory Category (categorical score; 0 to 5)
Measured: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Functional Independence Measure: locomotion
Functional Independence Measure (subscale of locomotion: 1 to 7)
Measured: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Modified falls efficacy scale
Modified falls efficacy scale (total score: 0 to 140)
Measured: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Presence of Fear of falling
Fear of falling (yes or no; by simple question "Are you afraid of falling?")
Measured: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Modified Barthel index
Modified Barthel index (tota; score: 0 to 100)
Measured: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Short physical performance scale
Short physical performance scale (total score: 0 to 12)
Measured: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2018Dec 2019

First posted7 Aug 2018
Study startAug 2018 (estimated)
Primary completionDec 2019 (estimated)
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hip FracturesStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03618576
Sponsor's protocol ID: 20-2018-46
Acronym: BRS
Status last verified: Aug 2018
First submitted: 19 Jul 2018
Last updated: 7 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

All Hip Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery
ClinicalTrials.gov ID: NCT03618576
Acronym / sponsor ID: BRS / 20-2018-46
Conditions: Hip Fractures
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Aug 2018 (estimated)
Primary completion: Dec 2019 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 7 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Balance exercise group	Experimental	Procedure: Balance specific exerciseDuring 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.

Who may qualify

Ages: 65 to 100 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Balance specific exerciseBalance 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.	Procedure or surgery	Balance exercise group

Primary outcome

Change of Berg balance scale
Time frame: Change from Baseline Berg balance scale at 6 months
Berg balance scale (total score; 0 to 56)

6 secondary outcomes

Functional Ambulatory Category
Time frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Functional Independence Measure: locomotion
Time frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Modified falls efficacy scale
Time frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Presence of Fear of falling
Time frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Modified Barthel index
Time frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery
Short physical performance scale
Time frame: Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Individual participant dataSharing planned: No

Related trials for Hip Fractures

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Balance specific exercise in people with Hip Fractures, run by Seoul National University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Berg balance scale (time frame: Change from Baseline Berg balance scale at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03618576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.