Neurocognitive Rehabilitation After Hip Replacement
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|ClinicalTrials.gov Identifier: NCT02231567|
Recruitment Status : Suspended
First Posted : September 4, 2014
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis||Other: Neurocognitive Rehabilitation Other: Traditional Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2014|
Experimental: Neurocognitive Rehabilitation
Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language).
Other: Neurocognitive Rehabilitation
The patients will be treated in inpatient clinic with a neurocognitive rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
Active Comparator: Traditional Rehabilitation
It is a rehabilitative approach based on exercises for the recovery of hip's range of motion, muscle strengthening exercises, stretching exercises of the hamstring muscles, adductor and iliopsoas and proprioceptive exercises.
Other: Traditional Rehabilitation
The patients will be treated in inpatient clinic with a traditional rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
- Change of WOMAC Questionnaire from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks ]Questionnaire for the assessment of pain, stiffness and physical function. It measures physical function and symptoms of the lower limb and explores the impact of disability and pain on activities of daily living. The questionnaire is self-administered and it is based on a metric scale ranging from 0 (no difficulty) to 100 (extreme difficulty).
- Change of Barthel Index from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks ]Index for the evaluation of patient's performance in activities of daily living. The index is divided into eleven sub-categories that assess activities of daily living (ability to feed themselves, to ensure personal hygiene and dressing) and the mobility of the individual (gait, postural changes and transfers, stairs). For each item is assigned a score variable from full to reduced or absent functionality. The questionnaire is administered by an examiner and is based on a metric scale ranging from 0 (total dependence) to 100 (minimum dependence).
- Change of Visual Analogue Scale (VAS) from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks ]It is based on a ten point scale, where 0 means no pain and 10 means the greatest pain ever. It enables the patients to express their pain intensity as numerical value.
- Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks ]Assessment of health status using the SF-36 Health Survey Questionnaire. The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional problems, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM). Indices are derived from 8 subcategories evaluated and allow to summarize the results. The questionnaire is self-administered and subcategories is that the indices are based on a metric scale ranging from 0 (worst health status) to 100 (best health status) 17, 18.
- Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks ]Questionnaire for the assessment of psychological well-being and positive functioning of the individual. It includes 84 items and measures the six dimensions /scales of well-being proposed in the model developed by the American psychologist Carol Ryff: self-acceptance, positive interpersonal relationships, autonomy, environmental control, personal growth and purpose in life. The questionnaire is self-administered and each item is evaluated by a metric scale ranging from 1 (disagree) to 6 (totally agree). The negatively worded items are counted in reverse order. The sum score for each scale is calculated by summing the degree of agreement of each item.
- Change of parameters of Gait Analysis from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks ]It's used to define the pattern of gait. The Gait Analysis provides different types of information such as quantitative kinematics data (angles of flexion-extension, abduction-adduction and external rotation of the main joints), velocity data (moments and powers the major joints) and electromyographic data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231567
|Umberto I Hospital|
|Rome, Italy, 00165|
|Principal Investigator:||Vincenzo Maria Saraceni||Umberto I Hospital, Sapienza University of Rome|