- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407444
Treatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture
A Comparison of Two Physiotherapy Treatment Protocols, With and Without Cycling Training , in Elderly Patients With Hip Fractures at Their Subacute Stage Following Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adults who have experienced a fall, followed by proximal hip fracture that required surgery, suffer from specific problems that interrupt the rehabilitation period in their subacute phase.
Various modes of treatment available as part of the physical rehabilitation but there is not enough data in the literature regarding the contribution of cycling training with leg cycle ergometer as part of conventional physiotherapy treatment in elderly patients after hip fracture surgery.
This study evaluates whether the additional cycling to physiotherapy treatment will improve the functional ability, the balance performance while standing, hip muscle strength and pain level in those patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Avital Hershkovitz, MD-PhD
- Phone Number: +972522342123
- Email: avitalhe@clalit.org.il
Study Contact Backup
- Name: Hila Dahan, BPT
- Phone Number: +972542458459
- Email: dahan.hila@gmail.com
Study Locations
-
-
-
Petach tiqva, Israel
- Recruiting
- "Beit- Rivka" geriatric rehabilitation hospital
-
Contact:
- Avital Hershkovitz, MD-PhD
- Phone Number: +97239373841
- Email: avitalhe@clalit.org.il
-
Contact:
- Hila Dahan, BPT
- Phone Number: +97239373839
- Email: dahan.hila@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Proximal hip fracture with full or partial weight bearing indication.
- Surgical fixation ( nailing or total hip replacement or hemiarthroplasty)
- Pre-morbid function: walking independently or under supervision with or without assistance aid
- Cognitive function: Mini-mental state examination score above 21
Exclusion Criteria:
- Pathological hip fracture.
- Unstable heart or pulmonary disease.
- Presence of other fractures as a result of the current fall.
- Neurological comorbidities ( CVA, Parkinson, MS ).
- Entering the rehabilitation center more than three weeks after hip surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiotherapy treatment & leg cycling
This group will receive conventional physiotherapy treatments, each session will last 30 minutes. Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress. In addition this group will have cycling training with leg cycle ergometer for 20 minutes. This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. |
All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group. In addition each patient in this group will train with stationary leg cycle ergometer for 20 minutes under physical therapist's supervision . Cycling exercise intensity subjectively determined by the patient using RPE Borg scale . Maximal intensity level determined as 14 in Borg scale. |
Active Comparator: Physiotherapy treatment & music listening
This group will receive conventional physiotherapy treatments, each session will last 30 minutes .Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress. In addition this group will listen to music (while sitting on a chair) for 20 minutes.This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. |
All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group. In addition each patient in this group will listen to music with earphone for 20 minutes while sitting under physical therapist supervision. Overall treatment session will last 50 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FIM ( functional independence measure)
Time Frame: baseline-at the first day of intervention
|
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living.
It contains 18 items composed of 13 motor tasks and 5 cognitive tasks.
Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence.
Score range from 18 (lowest) to 126 (highest) indicating level of function.
|
baseline-at the first day of intervention
|
Static balance test and weight bearing distribution while standing
Time Frame: baseline-at the first day of intervention
|
The balance and weight bearing distribution parameters will be evaluated by posturographic device .
This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves.
The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters.
Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
|
baseline-at the first day of intervention
|
Muscle strength
Time Frame: baseline-at the first day of intervention
|
Quadriceps strength and hand grip will be assessed by hand held dynamometer.
This is a quantitative and objective method for assessment of muscular strength.
Scored using force production in kilograms.
|
baseline-at the first day of intervention
|
Pain intensity (measured with VAS)
Time Frame: baseline-at the first day of intervention
|
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable.
The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
|
baseline-at the first day of intervention
|
Change from baseline in FIM at 2 weeks
Time Frame: Second week of intervention
|
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living.
It contains 18 items composed of 13 motor tasks and 5 cognitive tasks.
Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence.
Score range from 18 (lowest) to 126 (highest) indicating level of function.
|
Second week of intervention
|
Change from baseline in FIM at 3 weeks
Time Frame: End of intervention at third week
|
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living.
It contains 18 items composed of 13 motor tasks and 5 cognitive tasks.
Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence.
Score range from 18 (lowest) to 126 (highest) indicating level of function.
|
End of intervention at third week
|
Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks
Time Frame: Second week of intervention
|
The balance and weight bearing distribution parameters will be evaluated by posturographic device .
This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves.
The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters.
Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
|
Second week of intervention
|
Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks
Time Frame: End of intervention at third week
|
The balance and weight bearing distribution parameters will be evaluated by posturographic device .
This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves.
The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters.
Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
|
End of intervention at third week
|
Change from baseline in muscle strength at 2 weeks
Time Frame: Second week of intervention
|
Quadriceps strength and hand grip will be assessed by hand held dynamometer.
This is a quantitative and objective method for assessment of muscular strength.
Scored using force production in kilograms.
|
Second week of intervention
|
Change from baseline in muscle strength at 3 weeks
Time Frame: End of intervention at third week
|
Quadriceps strength and hand grip will be assessed by hand held dynamometer.
This is a quantitative and objective method for assessment of muscular strength.
Scored using force production in kilograms.
|
End of intervention at third week
|
Change from baseline in pain intensity at 2 weeks (measured with VAS)
Time Frame: Second week of intervention
|
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable.
The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
|
Second week of intervention
|
Change from baseline in pain intensity at 3 weeks (measured with VAS)
Time Frame: End of intervention at third week
|
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable.
The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
|
End of intervention at third week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Avital Hershkovitz, MD-PhD, Beit-Rivka Geriatric Rehabilitation Hospital
- Study Chair: Youssef Ma Masharawi, PhD, Tel Aviv University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rmc150495ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Smith & Nephew, Inc.Terminated
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
Carilion ClinicCompleted
-
FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
-
Rabin Medical CenterUnknown
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
Clinical Trials on Physiotherapy treatment & leg cycling
-
Manchester University NHS Foundation TrustUniversity of SalfordCompletedAcquired Brain InjuryUnited Kingdom
-
Franklin Pierce UniversityTerminatedHyperglycemia, PostprandialUnited States
-
University of OttawaThe Ottawa Hospital; Multiple Sclerosis Society of CanadaRecruiting
-
Universiti Teknologi MaraUniversity of MalayaCompletedINCOMPLETE SPINAL CORD INJURY (ASIA D)Malaysia
-
University Hospital OstravaCompletedMuscle Weakness | Mechanical Ventilation ComplicationCzechia
-
Hacettepe UniversityCompletedCerebral Palsy | Diplegic Cerebral Palsy
-
Cairo UniversityCompletedChronic Kidney Disease stage3Egypt
-
University of VictoriaUnknown
-
Norwegian University of Science and TechnologyCompletedPulmonary Disease, Chronic Obstructive | HyperoxiaNorway
-
University of WinchesterUniversity of Southampton; University of North Carolina, Chapel Hill; AlterG; University... and other collaboratorsCompletedStroke | Quality of Life | Vascular Stiffness | Gait, HemiplegicUnited Kingdom