TBI Traumatic Brain Injury Clinical Trial
Official title:
Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured Patients
| NCT number | NCT02331628 |
| Other study ID # | 20-13 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2014 |
| Est. completion date | September 13, 2018 |
| Verified date | February 2021 |
| Source | Loewenstein Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | September 13, 2018 |
| Est. primary completion date | September 13, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Age > 18 years - Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year. - Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information. Exclusion Criteria: - Pregnancy. - Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures - Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Loewenstein Rehabilitation Center | Ra'anana |
| Lead Sponsor | Collaborator |
|---|---|
| Loewenstein Hospital | James Cook University, Queensland, Australia, Medispec, University of Melbourne |
Israel,
Reznik JE, Biros E, Lamont AC, Sacher Y, Kibrik O, Milanese S, Gordon S, Galea MP. A preliminary investigation on the effect of extracorporeal shock wave therapy as a treatment for neurogenic heterotopic ossification following traumatic brain injury. Part — View Citation
Reznik JE, Biros E, Sacher Y, Kibrik O, Milanese S, Gordon S, Galea MP. A preliminary investigation on the effect of extracorporeal shock wave therapy as a treatment for neurogenic heterotopic ossification following traumatic brain injury. Part II: Effect — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change from Functional Independence Measure (FIM) at baseline | The Functional Independence Measure (FIM) assesses physical and cognitive disability. It consists of two subscales, motor and socio-cognitive with 18 assessable items in total. The tool is completed by observation of performance. The motor subscale, which is the portion to be assessed in this trial includes 13 items: eating, grooming bathing, dressing upper extremity, dressing lower extremity, bowel management, bladder management, transfers to bed, chair or wheelchair, transfer to tub, toilet and shower, walking or wheelchair propulsion and stair climbing. Each item is scored on a 7 point ordinal scale ranging from 1 (total dependence) to a score of 7 (total independence). Motor FIM scores range from 13 (total dependence) to 91 (total independence). Reliability and validity is well-established. The FIM has been translated into 10 languages, including English and Hebrew, the languages to be used in this study. | At baseline; then at 8, 16, 26 and 38 weeks | |
| Other | Range of Motion | Range of Motion (ROM) of the affected hip and knee will be measured using a universal goniometer, using the protocol described by Clarkson (2005). | Every two weeks from week 0 up to week 22; then at weeks 26 and 38 | |
| Other | Change from The European Quality Of Life -Dimensions questionnaire (EQ-5D) at baseline | The European Quality Of Life -Dimensions questionnaire (EQ-5D) is a standardised generic instrument designed for describing and valuing health by providing a single summary index value representing the overall health-related quality of life of an individual by quantifying a preference for his or her health state. The EQ-5D instrument consists of a self-classifier/ descriptive system to describe the respondent's own health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can value their health in each dimension at three ordinal levels: no problems, some or moderate problems, and severe or extreme problems. The second measurement component of the EQ-5D is a 20 cm vertical Visual Analogue Scale (EQ VAS) to rate the respondent's own health. The third component of the EQ-5D is a questionnaire on the respondent's background including medical history. | At baseline; 16,26 and 38 weeks | |
| Other | Change from Plain X-ray at baseline | Neurogenic Heterotopic Ossification (NHO) becomes evident on plain radiography approximately 2 to 6 weeks after clinical diagnosis (Freed, Hahn, Menter, & Dillon, 1982; Orzel & Rudd, 1985). An X-ray view will be set up for each patient and recorded so that it can be repeated. The view does not need to be a standard view; it is the patient's particular view that is important and reproducible. Measurements will be made along co-ordinates - set up for that patient - e.g. the largest and shortest diameters. Plain X-ray will be taken pre-intervention and six months post-intervention. Changes in the size of NHO will be calculated using UTHSCSA ImageTool (2002).plain radiography . | At baseline and six months post first intervention | |
| Other | Change from Serum Alkaline Phosphatase Levels (SAP) at baseline | Overview Alkaline Phosphatase Uses Preparation Procedure Risks Results More on Healthline
Part 1 of 7: Overview What Is an Alkaline Phosphatase Level Test? An alkaline phosphatase level test (ALP test) measures the amount of alkaline phosphatase enzyme in your bloodstream. The test requires a simple blood draw and is often a routine part of other blood tests. |
At base line, week 12, week 16, week 38 | |
| Primary | Change in Visual Analogue Scale (VAS) from baseline to final assessment | The Visual Analogue Pain Scale (VAS) will be used in its format of the Faces Rating Scale (FRS). The FRS is in the format of six facial expressions suggesting various pain intensities. The patient will be asked to choose the face that best describes how they feel. The far left face indicates 'No hurt' and the far right face indicates 'Hurts worst'. The number below the face chosen will be documented. | VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38. | |
| Secondary | Change from the 10 Metre Walk at baseline (if patient is ambulatory) | Temporal and distance measures (velocity, stride length, cadence) will be measured using the 10 metre walk test. | At baseline; weeks 16, 26 and 38 | |
| Secondary | Change from the 6 Minute Walk at baseline (if patient is ambulatory) | The patient is positioned at the start of the walking track and given the standardized instructions; "Walk as quickly as you can for six minutes to cover as much ground as possible. You may stop if you have to, but continue again as soon as you are able". On the instruction to start the therapist starts the stopwatch. At six minutes the patient is instructed to stop and the distance travelled is calculated. If the patient needs to stop, rest periods are included in the measurement time. | At baseline; weeks 16, 26 and 38 | |
| Secondary | Change from Functional Reach at baseline (if patient is able to stand) | The patient is instructed to stand next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. The patient is instructed to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. The difference between the start and end position is the reach distance, usually measured in centimeters.
Three trials are done and the average of the last two is noted. |
Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 | |
| Secondary | Change from Modified Functional Reach at baseline (if FR not possible) | Modified Functional Reach (MFR) is a reliable measure of sitting balance for those patients unable to stand. This test is performed with a leveled yardstick mounted on the wall at the height of the patient's acromion level while sitting in a chair. Hips, knees and ankles are positioned at 90 degree of flexion, with feet flat on the floor. The initial reach is measured with the patient sitting against the back of the chair with the arm flexed to 90 degrees. The measurement is taken from the distal end of the third metacarpal along the yardstick. There are three conditions over three trials:
Sitting with the arm near the wall and leaning forward Sitting with the back to the wall and leaning right Sitting with the back to the wall leaning left. Instructions are leaning as far as possible in each direction without rotation and without touching the wall. The distance in centimetres covered in each direction will be recorded. |
Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 |