The Effects of Exercise on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus
Study Details
Study Description
Brief Summary
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:
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Home based exercise program effective on balance, gait and performance
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home-Based Exercise Patients who perform home-based exercise program |
Other: Exercise Program
Stretching and strengthening exercises will be applied to the participants
|
| Experimental: Telerehabilitation Patients who perform telerehabilitation exercise program |
Other: Exercise Program
Stretching and strengthening exercises will be applied to the participants
|
| No Intervention: Control Group No intervention |
Outcome Measures
Primary Outcome Measures
- Postural Stability [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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
- Fall Risk [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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
- Modified Clinical Test of Sensory Integration of Balance [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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
- Walking Speed [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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.
- Cadence [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The test will perform with G-walk device.
- Stride Length [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The test will perform with G-walk device.
- Time Up and Go Test [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The test will perform with G-walk device.
- The Functional Independence Measure [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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.
- Muscle Strength [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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.
Secondary Outcome Measures
- Mini-mental state [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment
- The Montreal Cognitive Assessment (MoCA) [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.
- The Clinical Dementia Rating [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia
- The Geriatric Depression Scale [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly.
- The Cornell Scale for Depression in Dementia (CSDD) [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in demented patients.
- The Barthel scale [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL).
- The Lawton-Brody Instrumental Activities of Daily Living (iADL) [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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.
- The Tinetti-test [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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.
- The Nine-Hole Peg Test [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses
- Grip strength [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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
- Fried frailty scale [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
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.
- FRAIL scale [Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks]
FRAIL scale consists of 5 items; fatigue state, resistance, mobility, weight loss, and existing diseases.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 60-90 years old
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Fulfilling the following clinical criteria for iNPH, as proposed by the Relkin and colleagues
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Able to walk independently (without physical assistance from a person and/or a device)
Exclusion Criteria:
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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.
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Patients with diagnosis of seconder normal pressure hydrocephalus were also excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dokuz Eylul University | İzmir | Turkey | 35330 |
Sponsors and Collaborators
- Dokuz Eylul University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Nikaido Y, Kajimoto Y, Akisue T, Urakami H, Kawami Y, Kuroda K, Ohno H, Saura R. Dynamic Balance Measurements Can Differentiate Patients Who Fall From Patients Who Do Not Fall in Patients With Idiopathic Normal Pressure Hydrocephalus. Arch Phys Med Rehabil. 2019 Aug;100(8):1458-1466. doi: 10.1016/j.apmr.2019.01.008. Epub 2019 Feb 4.
- Nikaido Y, Urakami H, Okada Y, Kajimoto Y, Ishida N, Kawami Y, Akisue T, Saura R. Dynamic gait stability in patients with idiopathic normal pressure hydrocephalus with high and low fall-risk. Clin Biomech (Bristol, Avon). 2022 Oct;99:105757. doi: 10.1016/j.clinbiomech.2022.105757. Epub 2022 Sep 5.
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- Schniepp R, Trabold R, Romagna A, Akrami F, Hesselbarth K, Wuehr M, Peraud A, Brandt T, Dieterich M, Jahn K. Walking assessment after lumbar puncture in normal-pressure hydrocephalus: a delayed improvement over 3 days. J Neurosurg. 2017 Jan;126(1):148-157. doi: 10.3171/2015.12.JNS151663. Epub 2016 Mar 18.
- Sherafat S, Salavati M, Ebrahimi Takamjani I, Akhbari B, Mohammadirad S, Mazaheri M, Negahban H. Intrasession and intersession reliability of postural control in participants with and without nonspecific low back pain using the Biodex Balance System. J Manipulative Physiol Ther. 2013 Feb;36(2):111-8. doi: 10.1016/j.jmpt.2012.12.005.
- Son M, Cheon SM, Youm C, Kim JW. Turning reveals the characteristics of gait freezing better than walking forward and backward in Parkinson's disease. Gait Posture. 2022 May;94:131-137. doi: 10.1016/j.gaitpost.2022.03.009. Epub 2022 Mar 16.
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- Tisell M, Tullberg M, Hellstrom P, Edsbagge M, Hogfeldt M, Wikkelso C. Shunt surgery in patients with hydrocephalus and white matter changes. J Neurosurg. 2011 May;114(5):1432-8. doi: 10.3171/2010.11.JNS10967. Epub 2011 Jan 14.
- Viteckova S, Horakova H, Polakova K, Krupicka R, Ruzicka E, Brozova H. Agreement between the GAITRite(R) System and the Wearable Sensor BTS G-Walk(R) for measurement of gait parameters in healthy adults and Parkinson's disease patients. PeerJ. 2020 May 22;8:e8835. doi: 10.7717/peerj.8835. eCollection 2020.
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