Hip OsteoarthritisNCT02231567
Neurocognitive Rehabilitation After Hip Replacement
A study testing Neurocognitive Rehabilitation and Traditional Rehabilitation in people with Hip Osteoarthritis, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Neurocognitive Rehabilitation and Traditional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Dec 2015
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.
Who cannot join
- Different diagnosis from hip osteoarthritis (eg. Fracture)
- Concomitant osteoarthrosis of the hip or knee with gait restrictions
- Lameness for more than six months
- Central nervous system or Peripheral nervous system disorders
- Systemic inflammatory disorders (eg. Rheumatoid Arthritis)
- Systemic infectious disorders
Show all 12Show fewer
- Cognitive impairment
- Neoplastic disorders
- Surgical revisions
- Intraoperative complications
- Suspected hip replacement infection
- Hip replacement with endoprosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial
The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.
- Conditions
- Hip Osteoarthritis
- Being tested
- Neurocognitive Rehabilitation, Traditional Rehabilitation
- Keywords
- hip replacement, neurocognitive rehabilitation, WOMAC questionnaire
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive RehabilitationOther
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.
Traditional RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive Rehabilitation | Experimental | Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language). Receives: Other: Neurocognitive Rehabilitation |
| Traditional Rehabilitation | Active comparator | 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. Receives: Other: Traditional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of WOMAC Questionnaire from baseline to 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).
Measured: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Secondary outcomes (5)
Change of Barthel Index from baseline to 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).
Measured: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of Visual Analogue Scale (VAS) from baseline to 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.
Measured: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of SF-36 Health Survey Questionnaire from baseline to 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.
Measured: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of Psychological Well-Being Questionnaire (PWB) from baseline to 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.
Measured: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of parameters of Gait Analysis from baseline to 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.
Measured: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Vincenzo Maria Saraceni, Principal investigator, Umberto I Hospital, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231567
- Sponsor's protocol ID
- 3298/2014
- Status last verified
- Jan 2016
- First submitted
- 8 Aug 2014
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02231567
- Acronym / sponsor ID
- 3298/2014
- Conditions
- Hip Osteoarthritis
- Keywords
- hip replacement, neurocognitive rehabilitation, WOMAC questionnaire
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Sep 2014 (estimated)
- 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.
The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Rehabilitation | Experimental | Other: Neurocognitive RehabilitationRehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language). |
| Traditional Rehabilitation | Active comparator | Other: Traditional RehabilitationIt 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.
Key exclusion criteria (12 listed)
- Different diagnosis from hip osteoarthritis (eg. Fracture)
- Concomitant osteoarthrosis of the hip or knee with gait restrictions
- Lameness for more than six months
- Central nervous system or Peripheral nervous system disorders
- Systemic inflammatory disorders (eg. Rheumatoid Arthritis)
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 |
|---|---|---|
| Neurocognitive RehabilitationThe 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. | Other | Neurocognitive Rehabilitation |
| Traditional RehabilitationThe 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. | Other | Traditional Rehabilitation |
Primary outcome
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).
5 secondary outcomes
Change of Barthel Index from baseline to 24 weeks
Time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of Visual Analogue Scale (VAS) from baseline to 24 weeks
Time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks
Time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks
Time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Change of parameters of Gait Analysis from baseline to 24 weeks
Time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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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.
Vincenzo Maria Saraceni principal investigator
Umberto I Hospital, Sapienza University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive Rehabilitation and Traditional Rehabilitation in people with Hip Osteoarthritis, run by University of Roma La Sapienza at 1 site in Italy.
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 12 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: stopped early, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early. 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 WOMAC Questionnaire from baseline to 24 weeks (time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2020.