The Effects of Exercise on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus

NCT05679934 | Unknown

• 1 other identifier: deu-uyesil-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

NPH (Normal Pressure Hydrocephalus)

Keywords

balance; gait; performance

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (12)

• 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 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 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 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 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

Study Arms (3)

Home-Based Exercise

EXPERIMENTAL

Patients who perform home-based exercise program

Other: Exercise Program

Telerehabilitation

EXPERIMENTAL

Patients who perform telerehabilitation exercise program

Other: Exercise Program

Control Group

NO INTERVENTION

No intervention

Interventions

Exercise Program OTHER

Stretching and strengthening exercises will be applied to the participants

Home-Based Exercise; Telerehabilitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35330, Turkey (Türkiye)

RECRUITING

Related Publications (24)

• Chunyan L, Rongrong H, Youping W, Hongliang L, Qiong Y, Xing L, Yan X. Gait characteristics and effects of the cerebrospinal fluid tap test in probable idiopathic normal pressure hydrocephalus. Clin Neurol Neurosurg. 2021 Nov;210:106952. doi: 10.1016/j.clineuro.2021.106952. Epub 2021 Sep 20.

  PMID: 34619648 BACKGROUND

• Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.

  PMID: 5889177 BACKGROUND

• Gallagher R, Marquez J, Osmotherly P. Gait and Balance Measures Can Identify Change From a Cerebrospinal Fluid Tap Test in Idiopathic Normal Pressure Hydrocephalus. Arch Phys Med Rehabil. 2018 Nov;99(11):2244-2250. doi: 10.1016/j.apmr.2018.03.018. Epub 2018 Apr 25.

  PMID: 29702069 BACKGROUND

• Song M, Lieberman A, Fife T, Nielsen M, Hayden S, Sabbagh M, Shi J. A prospective study on gait dominant normal pressure hydrocephalus. Acta Neurol Scand. 2019 Apr;139(4):389-394. doi: 10.1111/ane.13064. Epub 2019 Feb 19.

  PMID: 30676642 BACKGROUND

• 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.

  PMID: 26991388 BACKGROUND

• Bottcher N, Bremova T, Feil K, Heinze C, Schniepp R, Strupp M. Normal pressure hydrocephalus: Increase of utricular input in responders to spinal tap test. Clin Neurophysiol. 2016 May;127(5):2294-301. doi: 10.1016/j.clinph.2016.01.027. Epub 2016 Feb 28.

  PMID: 27072102 BACKGROUND

• 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.

  PMID: 35306381 BACKGROUND

• Bovonsunthonchai S, Witthiwej T, Ngamsombat C, Sathornsumetee S, Vachalathiti R, Muangpaisan W, Hengsomboon P, Thong-On S, Jankhum S, Yangyoo P. Effect of spinal tap test on the performance of sit-to-stand, walking, and turning in patients with idiopathic normal pressure hydrocephalus. Nagoya J Med Sci. 2018 Feb;80(1):53-60. doi: 10.18999/nagjms.80.1.53.

  PMID: 29581614 BACKGROUND

• Andren K, Wikkelso C, Tisell M, Hellstrom P. Natural course of idiopathic normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2014 Jul;85(7):806-10. doi: 10.1136/jnnp-2013-306117. Epub 2013 Nov 29.

  PMID: 24292998 BACKGROUND

• Isik AT, Kaya D, Ates Bulut E, Dokuzlar O, Soysal P. The Outcomes Of Serial Cerebrospinal Fluid Removal In Elderly Patients With Idiopathic Normal Pressure Hydrocephalus. Clin Interv Aging. 2019 Nov 19;14:2063-2069. doi: 10.2147/CIA.S228257. eCollection 2019.

  PMID: 31819388 BACKGROUND

• 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.

  PMID: 21235310 BACKGROUND

• Relkin N, Marmarou A, Klinge P, Bergsneider M, Black PM. Diagnosing idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Sep;57(3 Suppl):S4-16; discussion ii-v. doi: 10.1227/01.neu.0000168185.29659.c5.

  PMID: 16160425 BACKGROUND

• 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.

  PMID: 32509441 BACKGROUND

• 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.

  PMID: 23499146 BACKGROUND

• Prometti P, Olivares A, Gaia G, Bonometti G, Comini L, Scalvini S. Biodex Fall Risk Assessment in the Elderly With Ataxia: A New Age-Dependent Derived Index in Rehabilitation: An Observational Study. Medicine (Baltimore). 2016 Mar;95(10):e2977. doi: 10.1097/MD.0000000000002977.

  PMID: 26962804 BACKGROUND

• Lim TS, Yong SW, Moon SY. Repetitive lumbar punctures as treatment for normal pressure hydrocephalus. Eur Neurol. 2009;62(5):293-7. doi: 10.1159/000235808. Epub 2009 Aug 27.

  PMID: 19713705 BACKGROUND

• Rossi PD, Damanti S, Nani C, Pluderi M, Bertani G, Mari D, Cesari M, Consonni D, Spagnoli D. Repeated Cerebrospinal Fluid Removal Procedure in Older Patients With Idiopathic Normal Pressure Hydrocephalus Ineligible for Surgical Treatment. J Am Med Dir Assoc. 2019 Mar;20(3):373-376.e3. doi: 10.1016/j.jamda.2018.11.014. Epub 2019 Jan 9.

  PMID: 30638833 BACKGROUND

• Larsson J, Israelsson H, Eklund A, Lundin-Olsson L, Malm J. Falls and Fear of Falling in Shunted Idiopathic Normal Pressure Hydrocephalus-The Idiopathic Normal Pressure Hydrocephalus Comorbidity and Risk Factors Associated With Hydrocephalus Study. Neurosurgery. 2021 Jun 15;89(1):122-128. doi: 10.1093/neuros/nyab094.

  PMID: 33830219 BACKGROUND

• 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.

  PMID: 30731067 BACKGROUND

• 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). 2022 Oct;99:105757. doi: 10.1016/j.clinbiomech.2022.105757. Epub 2022 Sep 5.

  PMID: 36113194 BACKGROUND

• Abram K, Bohne S, Bublak P, Karvouniari P, Klingner CM, Witte OW, Guntinas-Lichius O, Axer H. The Effect of Spinal Tap Test on Different Sensory Modalities of Postural Stability in Idiopathic Normal Pressure Hydrocephalus. Dement Geriatr Cogn Dis Extra. 2016 Sep 27;6(3):447-457. doi: 10.1159/000450602. eCollection 2016 Sep-Dec.

  PMID: 27790243 BACKGROUND

• Lundin F, Ledin T, Wikkelso C, Leijon G. Postural function in idiopathic normal pressure hydrocephalus before and after shunt surgery: a controlled study using computerized dynamic posturography (EquiTest). Clin Neurol Neurosurg. 2013 Sep;115(9):1626-31. doi: 10.1016/j.clineuro.2013.02.015. Epub 2013 Mar 11.

  PMID: 23489444 BACKGROUND

• Hess T, Milani TL, Meixensberger J, Krause M. Postural performance and plantar cutaneous vibration perception in patients with idiopathic normal pressure hydrocephalus. Heliyon. 2020 Dec 31;7(1):e05811. doi: 10.1016/j.heliyon.2020.e05811. eCollection 2021 Jan.

  PMID: 33458441 BACKGROUND

• Ishikawa M, Yamada S, Yamamoto K. Early and delayed assessments of quantitative gait measures to improve the tap test as a predictor of shunt effectiveness in idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2016 Nov 22;13(1):20. doi: 10.1186/s12987-016-0044-z.

  PMID: 27876063 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

ÜMİT YEŞİL

CONTACT

+905384834145; fztumityesil@gmail.com

NİHAL GELECEK

CONTACT

+905055250323; ngelecek71@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research asistant

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: January 11, 2023
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)