NPH (Normal Pressure Hydrocephalus) Clinical Trial
Official title:
The Effects of Home-Based Exercise Program And Telerehabilitation on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus Applied With Lumbar Puncture
The goal of this study is to investigate effect of exercise program on balance, gait and performance in patients with normal pressure hydrocephalus applied with lumbar puncture. The main question it aims to answer are: - Home based exercise program effective on balance, gait and performance - Telerehabilitation exercise program effective on balance, gait and performance Researchers will compare home based exercise group, telerehabilitation group and control group to see if difference in terms of balance, gait and performance
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | June 1, 2024 |
| Est. primary completion date | June 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | Inclusion Criteria: - Age 60-90 years old - Fulfilling the following clinical criteria for iNPH, as proposed by the Relkin and colleagues - Able to walk independently (without physical assistance from a person and/or a device) Exclusion Criteria: - Patients who had severe physical disability or immobility, major primary psychiatric disorders (eg, schizophrenia, bipolar disorder), unstable major medical illnesses (eg, acute coronary syndrome, respiratory failure), acute cerebrovascular disease, severe visual or hearing impairments were excluded. - Patients with diagnosis of seconder normal pressure hydrocephalus were also excluded. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Dokuz Eylul University | Izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Dokuz Eylul University |
Turkey,
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* Note: There are 24 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postural Stability | Biodex Balance System was used to measure balance-related variables. Biodex has a fixable and movable platform and a touch screen on which the participant can visually track his/her movements.The Postural Stability test emphasizes a patient's ability to maintain center of balance. The device measures anterior-posterior (AP) and medial-lateral (ML) oscillations of the participant and provides anterior-posterior index, medial-lateral index and total stability index scores. Since these scores assess deviations from center, a lower score is more desirable than a higher score | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Fall Risk | Biodex Balance System was used to measure balance-related variables.Fall Risk test measures the patient's postural sway velocity to predict risk. There is a circular platform that moves freely and simultaneously about the anterior-posterior and medial-lateral axes and provides overall stabiliy index score. The index of overall stability is measured in degrees and higher scores indicate poor dynamic balance | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Modified Clinical Test of Sensory Integration of Balance | Biodex Balance System was used to measure balance-related variables. mCTSIB provides a generalized assessment of how well patient can integrate various senses with respect to balance and compensate when one or more of those senses are compromised. mCTSIB was performed in four different conditions: eyes open-firm surface (EO-firm), eyes closed-firm surface (EC-firm), eyes open-foam surface (EO- foam), eyes closed-foam surface (EC-foam). The device computes an overall sway index as the standard deviation of the recorded position away from the center. Higher sway index scores indicate greater deviations from the center, therefore, lower scores reflect better response | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Walking Speed | The gait characteristics was measured using G-Walk sensor system. The BTS G-Walk (G-Sensor 2) is a portable, wireless, inertial system with wearable sensors. Each participant was asked to walk down a hallway through a central 7- meter "testing" zone, instructed to walk at his/her ordinary comfortable walking speed and return start line. The acquired data is transmitted via a Bluetooth connection to a computer and processed using the special software program BTS G-Studio. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Cadence | The test will perform with G-walk device. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Stride Length | The test will perform with G-walk device. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Time Up and Go Test | The test will perform with G-walk device. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | The Functional Independence Measure | The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients.FIM is an 18-item, clinician reported scale that assesses an individuals functional capability in six areas including self-care, continence, mobility, transfers, communication and cognition. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Primary | Muscle Strength | We measured knee extensor and ankle dorsi flexor muscle strength using a hand-held dynamometer. Participants were asked to seat on a bedside (height 100 cm) with hip and knee at 90 degree flexion. Three measurements were taken for each muscle group and the highest score was recorded in kg. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | Mini-mental state | The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Clinical Dementia Rating | The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Geriatric Depression Scale | The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Cornell Scale for Depression in Dementia (CSDD) | The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in demented patients. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Barthel scale | The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Lawton-Brody Instrumental Activities of Daily Living (iADL) | The Lawton-Brody Instrumental Activities of Daily Living (iADL) scale covers eight functional domains: using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Tinetti-test | The Tinetti-test, also called Performance-Oriented Mobility Assessment (POMA) assesses a person's perception of balance and stability during activities of daily living and their fear of falling. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | The Nine-Hole Peg Test | The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | Grip strength | Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | Fried frailty scale | Fried frailty scale is the very first and most commonly used assessment scale for an operational definition of physical frailty with its demonstrated success as a predictor of mobility limitations and mortality. Fried frailty scale includes five components, among which three or more were defined as frailty: unintentional weight loss (10 lbs in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks | |
| Secondary | FRAIL scale | FRAIL scale consists of 5 items; fatigue state, resistance, mobility, weight loss, and existing diseases. | Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks |
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