The gait in idiopathic normal pressure hydrocephalus study
- Conditions
- Idiopathic normal pressure hydrocephalusNervous System Diseases
- Registration Number
- ISRCTN14305388
- Lead Sponsor
- Salford Royal NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
1. Consenting males and females diagnosed with iNPH according to the international guidelines for diagnosing iNPH. Patients younger than age 60 may be included on a case by case basis.
2. Should be able to walk unaided for at least 20 steps at a time; walking aids will be permitted to reflect the reality of this condition for many patients.
3. Consenting healthy volunteers, of similar age and sex distribution, without iNPH. Chronic stable health conditions and chronic stable medications (e.g. hypertension on long term antihypertensive medication) with no substantive impact on performance and participation in this study as judged by the investigators are permitted.
1. Other confirmed medical or surgical conditions better explaining symptoms than iNPH (patients) or with substantive impact (eg Parkinson’s, osteoarthritis) as judged by the investigators (patients and control)
2. Secondary or obstructive hydrocephalus; previous surgical procedures for hydrocephalus (patients)
3. Amputation of lower limb/appendages
4. Musculoskeletal injury/recent lower-limb surgeries affecting gait or other musculoskeletal ailments affecting gait and balance performance as judged by the investigators
5. Participants on specific medications (eg centrally acting) better explaining symptoms than iNPH (patients) or with substantive impact as judged by the investigators (patients and control)
6. Unable to carry out all study procedures
7. Unable to comprehend informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All measures are assessed ~1 week apart (~7 days pre- and within 72hrs post-lumbar puncture for pwN); controls test only once<br>Gait lab assessments will include:<br>1. 10-minute walk test<br>2. Timed up and go test<br>3. 360-degree turn test<br>4. Balance tests (quiet stance (60 seconds)<br>5. Single leg stance (seconds able)<br>6. Romberg test (seconds able to stand with eyes closed)<br><br>Variables to be included in analyses from above are those found in standard 3d gait and balance assessments:<br>Kinetic variables of interest will include forces (mediolateral, anteroposterior, and vertical ground reaction forces; joint forces, moments and powers) and centre of pressure<br>Kinematic variables of interest will include joint angles, angular velocities, whole body centre of mass displacement/velocity/acceleration, temporospatial measures (walking distance/time/speed; stride length, width, cadence)
- Secondary Outcome Measures
Name Time Method Psychological factors will be monitored in patients (part of the clinical routine) and controls before, 1 h and 24 hours post lumbar puncture, and each time before and after mobility assessments:<br>1. Anxiety and depression symptoms measured using the Hospital Anxiety and Depression Scale when they attend the gait laboratory<br>2. Quality of life measured using:<br>2.1. Patient version of the EQ-5D-5L in patients as part of the clinical routine and in controls when they attend the gait laboratory<br>2.2. Proxy version of the EQ-5D-5L in patients only as part of the clinical routine<br>3. Carer burden measured using the Burden Scale for Family Caregivers in patients only as part of the clinical routine <br><br>Step counts, distance walked, heart rate (resting; variability), skin temp variation, breathing rate, sleep tracking and calories expended measured using Fitbit data in the 3 days pre-LP and 1 week post LP