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

NCT ID: NCT05679934

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-06-01

Brief Summary

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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

Detailed Description

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Conditions

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NPH (Normal Pressure Hydrocephalus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Home-Based Exercise

Patients who perform home-based exercise program

Group Type EXPERIMENTAL

Exercise Program

Intervention Type OTHER

Stretching and strengthening exercises will be applied to the participants

Telerehabilitation

Patients who perform telerehabilitation exercise program

Group Type EXPERIMENTAL

Exercise Program

Intervention Type OTHER

Stretching and strengthening exercises will be applied to the participants

Control Group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Program

Stretching and strengthening exercises will be applied to the participants

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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ümit yeşil

research asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ÜMİT YEŞİL

Role: CONTACT

+905384834145

NİHAL GELECEK

Role: CONTACT

+905055250323

Facility Contacts

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ahmet turan ışık, Prof.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 34619648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5889177 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 35306381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29581614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24292998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31819388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21235310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16160425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32509441 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 19713705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30638833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33830219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30731067 (View on PubMed)

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.

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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.

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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.

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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.

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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.

Reference Type BACKGROUND
PMID: 27876063 (View on PubMed)

Other Identifiers

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deu-uyesil-001

Identifier Type: -

Identifier Source: org_study_id

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