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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02407444
Other study ID # rmc150495ctil
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 19, 2015
Last updated April 2, 2015
Start date May 2015
Est. completion date December 2016

Study information

Verified date March 2015
Source Rabin Medical Center
Contact Avital Hershkovitz, MD-PhD
Phone +972522342123
Email avitalhe@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy treatment & leg cycling
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.
Physiotherapy treatment & music listening
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.

Locations

Country Name City State
Israel "Beit- Rivka" geriatric rehabilitation hospital Petach tiqva

Sponsors (2)

Lead Sponsor Collaborator
Rabin Medical Center Beit-Rivka Geriatric Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary FIM ( functional independence measure) 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 No
Primary Static balance test and weight bearing distribution while standing 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 No
Primary Muscle strength 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 No
Primary Pain intensity (measured with VAS) 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 No
Primary Change from baseline in FIM at 2 weeks 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 No
Primary Change from baseline in FIM at 3 weeks 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 No
Primary Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks 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 No
Primary Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks 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 No
Primary Change from baseline in muscle strength at 2 weeks 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
Primary Change from baseline in muscle strength at 3 weeks 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 No
Primary Change from baseline in pain intensity at 2 weeks (measured with VAS) 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 No
Primary Change from baseline in pain intensity at 3 weeks (measured with VAS) 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 No
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