Gait Pattern and Experienced Global Change After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus

NCT04795089 | Unknown

• 1 other identifier: 2020-00719
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Part 1 Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable disabilities regarding gait, balance, cognition and continence. Analysis of the gait pattern in iNPH has an important part in clinical diagnosing and evaluation of outcome after shunt surgery. The gait pattern is only partly explained and more detailed information about gait in iNPH is needed in relation with ordinary clinical measurements. Part 2 Approximately 70 % of patients with iNPH improve after shunt surgery. Commonly different grading scales and measurements regarding functions are used in the evaluation. To some extent, patients improve in Quality of life after surgery (QoL). In this study, the patient´s own grading of improvements in relation with QoL, sense of coherence (SOC) and symptoms of depression and anxiety are analyzed.

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

gait analysis; outcome; surgery

Outcome Measures

Primary Outcomes (17)

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed distance (m)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride duration (seconds)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride length (cm)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Cadence (steps per minute)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Gait phases (seconds)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Heel strike and Toe of angle (angle degree)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Circumduction (cm)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Ankle joint angle (degree of angle)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Knee joint angle (degree of angle)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable:Hip joint angle (degree of angle)

  Measurement in part 1. Mobile gait analysis system.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Grading of severity in idiopathic normal pressure hydrocephalus assessed with the Idiopathic Normal Pressure Hydrocephalus Scale

  Measurement in part 1 and part 2. Scores 0-100, higher scores mean a better outcome.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Mobility, walking ability and balance assessed with the Timed up and Go test

  Measurement in part 1. Variables: Time in seconds and number of steps.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Rating of global change assessed with the Global Rating of Change Scale

  Measurement in part 2. Scores -5-5 in global change, gait, balance, continence and cognition. Higher scores mean a better outcome.

  Rating at 3 month follow-up for patients.

• Sense of Coherence assessed with the 29 item Orientation to life questionnaire - swedish version (KASAM questionnaire)

  Measurement in part 2. Scores 29-203, higher scores mean a better outcome.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Anxiety and depression assessed with the Hospital Anxiety and Depression Scale

  Measurement in part 2. Anxiety scores 0-21, Depression scores 0-21, lower scores mean a better outcome.

  Change from baseline to 3 month follow-up for patients. Once for HI.

• Health-related quality of life assessed with EQ-5D-5L

  Measurement in part 2. Scores 5-25, higher scores mean a better outcome.

  Change from baseline to 3 month follow-up for patients. Once for HI.

Study Arms (2)

Patients

Patients with iNPH and shunt surgery.

Procedure: Shunt surgery

Healthy individuals

Healthy controls with similar gender and age distribution as the patients.

Interventions

Shunt surgery PROCEDURE

Patients are evaluated before and after shunt surgery which is a standard intervention in the clinical practice. HI do not undergo intervention.

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients: Al consecutively available patients evaluated for iNPH at Neurology department Linköping University hospital. HI: Convenience sample among relatives, friends and using advertising.

You may qualify if:

• iNPH-diagnosis according to the international guidelines (2005)
• Planed for shunt surgery

You may not qualify if:

• Cognitive impairment that makes it impossible to participate
• Not able to walk 20 meters without walking aids (part 1)
• \> 60 years of age
• Subjectively healthy without any serious disease
• Visible gait- or balance disturbance
• Dementia diagnosis

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Neurology department, Linköping University Hospital

Linköping, Sweden

Location

Related Publications (28)

• 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

• Klinge P, Hellstrom P, Tans J, Wikkelso C; European iNPH Multicentre Study Group. One-year outcome in the European multicentre study on iNPH. Acta Neurol Scand. 2012 Sep;126(3):145-53. doi: 10.1111/j.1600-0404.2012.01676.x. Epub 2012 May 10.

  PMID: 22571428 BACKGROUND

• Shore WS, deLateur BJ, Kuhlemeier KV, Imteyaz H, Rose G, Williams MA. A comparison of gait assessment methods: Tinetti and GAITRite electronic walkway. J Am Geriatr Soc. 2005 Nov;53(11):2044-5. doi: 10.1111/j.1532-5415.2005.00479_9.x. No abstract available.

  PMID: 16274403 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

• Selge C, Schoeberl F, Zwergal A, Nuebling G, Brandt T, Dieterich M, Schniepp R, Jahn K. Gait analysis in PSP and NPH: Dual-task conditions make the difference. Neurology. 2018 Mar 20;90(12):e1021-e1028. doi: 10.1212/WNL.0000000000005168. Epub 2018 Feb 21.

  PMID: 29467306 BACKGROUND

• Lim YH, Ko PW, Park KS, Hwang SK, Kim SH, Han J, Yoon U, Lee HW, Kang K. Quantitative Gait Analysis and Cerebrospinal Fluid Tap Test for Idiopathic Normal-pressure Hydrocephalus. Sci Rep. 2019 Nov 7;9(1):16255. doi: 10.1038/s41598-019-52448-3.

  PMID: 31700018 BACKGROUND

• Najafi B, Helbostad JL, Moe-Nilssen R, Zijlstra W, Aminian K. Does walking strategy in older people change as a function of walking distance? Gait Posture. 2009 Feb;29(2):261-6. doi: 10.1016/j.gaitpost.2008.09.002. Epub 2008 Oct 25.

  PMID: 18952435 BACKGROUND

• Konig N, Singh NB, von Beckerath J, Janke L, Taylor WR. Is gait variability reliable? An assessment of spatio-temporal parameters of gait variability during continuous overground walking. Gait Posture. 2014;39(1):615-7. doi: 10.1016/j.gaitpost.2013.06.014. Epub 2013 Jul 6.

  PMID: 23838361 BACKGROUND

• Donath L, Faude O, Lichtenstein E, Pagenstert G, Nuesch C, Mundermann A. Mobile inertial sensor based gait analysis: Validity and reliability of spatiotemporal gait characteristics in healthy seniors. Gait Posture. 2016 Sep;49:371-374. doi: 10.1016/j.gaitpost.2016.07.269. Epub 2016 Jul 30.

  PMID: 27494305 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Hellstrom P, Klinge P, Tans J, Wikkelso C. A new scale for assessment of severity and outcome in iNPH. Acta Neurol Scand. 2012 Oct;126(4):229-37. doi: 10.1111/j.1600-0404.2012.01677.x. Epub 2012 May 16.

  PMID: 22587624 BACKGROUND

• Toma AK, Papadopoulos MC, Stapleton S, Kitchen ND, Watkins LD. Systematic review of the outcome of shunt surgery in idiopathic normal-pressure hydrocephalus. Acta Neurochir (Wien). 2013 Oct;155(10):1977-80. doi: 10.1007/s00701-013-1835-5. Epub 2013 Aug 23.

  PMID: 23975646 BACKGROUND

• Israelsson H, Eklund A, Malm J. Cerebrospinal Fluid Shunting Improves Long-Term Quality of Life in Idiopathic Normal Pressure Hydrocephalus. Neurosurgery. 2020 Apr 1;86(4):574-582. doi: 10.1093/neuros/nyz297.

  PMID: 31504827 BACKGROUND

• Junkkari A, Sintonen H, Nerg O, Koivisto AM, Roine RP, Viinamaki H, Soininen H, Jaaskelainen JE, Leinonen V. Health-related quality of life in patients with idiopathic normal pressure hydrocephalus. Eur J Neurol. 2015 Oct;22(10):1391-9. doi: 10.1111/ene.12755. Epub 2015 Jun 24.

  PMID: 26104064 BACKGROUND

• Junkkari A, Hayrinen A, Rauramaa T, Sintonen H, Nerg O, Koivisto AM, Roine RP, Viinamaki H, Soininen H, Luikku A, Jaaskelainen JE, Leinonen V. Health-related quality-of-life outcome in patients with idiopathic normal-pressure hydrocephalus - a 1-year follow-up study. Eur J Neurol. 2017 Jan;24(1):58-66. doi: 10.1111/ene.13130. Epub 2016 Sep 19.

  PMID: 27647684 BACKGROUND

• Junkkari A, Roine RP, Luikku A, Rauramaa T, Sintonen H, Nerg O, Koivisto AM, Hayrinen A, Viinamaki H, Soininen H, Jaaskelainen JE, Leinonen V. Why Does the Health-Related Quality of Life in Idiopathic Normal-Pressure Hydrocephalus Fail to Improve Despite the Favorable Clinical Outcome? World Neurosurg. 2017 Dec;108:356-366. doi: 10.1016/j.wneu.2017.08.170. Epub 2017 Sep 5.

  PMID: 28887286 BACKGROUND

• Cage TA, Auguste KI, Wrensch M, Wu YW, Gupta N. Self-reported functional outcome after surgical intervention in patients with idiopathic normal pressure hydrocephalus. J Clin Neurosci. 2011 May;18(5):649-54. doi: 10.1016/j.jocn.2010.08.028. Epub 2011 Mar 2.

  PMID: 21371890 BACKGROUND

• Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

  PMID: 20046623 BACKGROUND

• Gallagher R, Marquez J, Osmotherly P. Clinimetric Properties and Minimal Clinically Important Differences for a Battery of Gait, Balance, and Cognitive Examinations for the Tap Test in Idiopathic Normal Pressure Hydrocephalus. Neurosurgery. 2019 Jun 1;84(6):E378-E384. doi: 10.1093/neuros/nyy286.

  PMID: 30010977 BACKGROUND

• Langius A, Bjorvell H, Antonovsky A. The sense of coherence concept and its relation to personality traits in Swedish samples. Scand J Caring Sci. 1992;6(3):165-71. doi: 10.1111/j.1471-6712.1992.tb00146.x.

  PMID: 1439378 BACKGROUND

• Kristofferzon ML, Engstrom M, Nilsson A. Coping mediates the relationship between sense of coherence and mental quality of life in patients with chronic illness: a cross-sectional study. Qual Life Res. 2018 Jul;27(7):1855-1863. doi: 10.1007/s11136-018-1845-0. Epub 2018 Apr 5.

  PMID: 29623597 BACKGROUND

• Sinikallio S, Pakarinen M, Tuomainen I, Airaksinen O, Viinamaki H, Aalto TJ. Preoperative sense of coherence associated with the 10-year outcomes of lumbar spinal stenosis surgery. J Health Psychol. 2019 Jun;24(7):989-997. doi: 10.1177/1359105316687633. Epub 2017 Jan 17.

  PMID: 28810389 BACKGROUND

• Israelsson H, Allard P, Eklund A, Malm J. Symptoms of Depression are Common in Patients With Idiopathic Normal Pressure Hydrocephalus: The INPH-CRasH Study. Neurosurgery. 2016 Feb;78(2):161-8. doi: 10.1227/NEU.0000000000001093.

  PMID: 26528670 BACKGROUND

• Antonovsky H, Sagy S. The development of a sense of coherence and its impact on responses to stress situations. J Soc Psychol. 1986 Apr;126(2):213-25. No abstract available.

  PMID: 3724090 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.

  PMID: 10158943 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Rydja J, Pohl P, Eleftheriou A, Lundin F. Gait characteristics in idiopathic normal pressure hydrocephalus: A controlled study using an inertial sensor system. PLoS One. 2025 Feb 26;20(2):e0317901. doi: 10.1371/journal.pone.0317901. eCollection 2025.

  PMID: 40009597 DERIVED

Study Officials

• Fredrik Lundin, PhD

  Neurology department, Linköping University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 12, 2021
• Study Start: March 11, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

SE (1)