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

Idiopathic Normal Pressure Hydrocephalus Clinical Trial

Official title:

Gait Pattern, Experienced Global Change, Sense of Coherence, Quality of Life, Anxiety and Depression Symptoms After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus, in Relation With Healthy Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04795089
• Other study ID #: 2020-00719
• Status: Active, not recruiting
• Start date: March 11, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Consecutive patients with iNPH, which are planed for shunt surgery at the neurological and neurosurgical departments of University Hospital of Linköping, are included. Before operation and 3 months postoperatively, the patient´s gait pattern are analyzed with RehaGait analysis system. The patients also fill in a questionnaire about SOC, QoL and symptoms of depression and anxiety at these assessment sessions. Additionally at the follow up, the patients are grading their overall experienced change and specified changes in gait, balance, continence and neuropsychology with the global Rating of Change Scale (GRC-scale). At baseline and at follow up, the patients also perform the ordinary clinical assessments with measurements covering the domains gait, balance, continence and neuropsychology in the iNPH-scale. A convenience sample of Healthy individuals aged > 60 years, conduct the same questionnaires: SOC, QoL and symptoms of depression and anxiety and perform the RehaGait analysis system once.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria for patients:

• iNPH-diagnosis according to the international guidelines (2005)

• Planed for shunt surgery

Exclusion criteria for patients:

• Cognitive impairment that makes it impossible to participate

• Not able to walk 20 meters without walking aids (part 1)

Inclusion criteria for healthy individuals:

• > 60 years of age

• Subjectively healthy without any serious disease

Exclusion criteria healthy individuals:

• Visible gait- or balance disturbance

• Dementia diagnosis

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Idiopathic Normal Pressure Hydrocephalus

Intervention

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

Locations

Country	Name	City	State
Sweden	Neurology department, Linköping University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (27)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Am Geriatr Soc. 2006 Jan;54(1):190. Imteyez, Hejab [corrected to Imteyaz, Hejab]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.