Idiopathic Normal Pressure HydrocephalusNCT04795089
Gait Pattern and Experienced Global Change After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
An observational study of Idiopathic Normal Pressure Hydrocephalus, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus
- What is being tested?
- Shunt surgery
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- 11 Mar 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- iNPH-diagnosis according to the international guidelines (2005)
- Planed for shunt surgery
- > 60 years of age
- Subjectively healthy without any serious disease
Who cannot join
- Cognitive impairment that makes it impossible to participate
- Not able to walk 20 meters without walking aids (part 1)
- Visible gait- or balance disturbance
- Dementia diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Being tested
- Shunt surgery
- Keywords
- gait analysis, outcome, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shunt surgeryProcedure or surgery
Patients are evaluated before and after shunt surgery which is a standard intervention in the clinical practice. HI do not undergo intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with iNPH and shunt surgery. Receives: Procedure: Shunt surgery | |
| Healthy individuals | Healthy controls with similar gender and age distribution as the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).
Measurement in part 1. Mobile gait analysis system.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 3 month follow-up for patients. Once for HI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start11 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fredrik Lundin, Linkoeping University
- Investigators
- Fredrik Lundin, PhD, Study director, Neurology department, Linköping University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795089
- Sponsor's protocol ID
- 2020-00719
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16160425Klinge 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.
PubMed 22571428Shore 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.
PubMed 16274403Schniepp 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.
PubMed 26991388Selge 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.
PubMed 29467306Lim 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.
PubMed 31700018Najafi 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.
PubMed 18952435Konig 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.
PubMed 23838361Donath 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.
PubMed 27494305Podsiadlo 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.
PubMed 1991946Hellstrom 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.
PubMed 22587624Toma 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.
PubMed 23975646Israelsson 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.
PubMed 31504827Junkkari 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.
PubMed 26104064Junkkari 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.
PubMed 27647684
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04795089
- Acronym / sponsor ID
- 2020-00719
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- gait analysis, outcome, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Shunt surgeryPatients with iNPH and shunt surgery. |
| Healthy individuals | – | –Healthy controls with similar gender and age distribution as the patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- iNPH-diagnosis according to the international guidelines (2005)
- Planed for shunt surgery
- > 60 years of age
- Subjectively healthy without any serious disease
Key exclusion criteria (4 listed)
- Cognitive impairment that makes it impossible to participate
- Not able to walk 20 meters without walking aids (part 1)
- Visible gait- or balance disturbance
- Dementia diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shunt surgeryPatients are evaluated before and after shunt surgery which is a standard intervention in the clinical practice. HI do not undergo intervention. | Procedure or surgery | Patients |
Primary outcome
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed distance (m)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride duration (seconds)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride length (cm)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Cadence (steps per minute)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Gait phases (seconds)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Heel strike and Toe of angle (angle degree)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Circumduction (cm)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Ankle joint angle (degree of angle)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Knee joint angle (degree of angle)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable:Hip joint angle (degree of angle)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Grading of severity in idiopathic normal pressure hydrocephalus assessed with the Idiopathic Normal Pressure Hydrocephalus Scale
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1 and part 2. Scores 0-100, higher scores mean a better outcome.
Mobility, walking ability and balance assessed with the Timed up and Go test
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Variables: Time in seconds and number of steps.
Rating of global change assessed with the Global Rating of Change Scale
Time frame: Rating at 3 month follow-up for patients.
Measurement in part 2. Scores -5-5 in global change, gait, balance, continence and cognition. Higher scores mean a better outcome.
Sense of Coherence assessed with the 29 item Orientation to life questionnaire - swedish version (KASAM questionnaire)
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Scores 29-203, higher scores mean a better outcome.
Anxiety and depression assessed with the Hospital Anxiety and Depression Scale
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Anxiety scores 0-21, Depression scores 0-21, lower scores mean a better outcome.
Health-related quality of life assessed with EQ-5D-5L
Time frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Scores 5-25, higher scores mean a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 16160425Relkin 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.
- Background: PubMed 22571428Klinge 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.
- Background: PubMed 16274403Shore 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.
- Background: PubMed 26991388Schniepp 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.
- Background: PubMed 29467306Selge 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.
- Background: PubMed 31700018Lim 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.
- Background: PubMed 18952435Najafi 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.
- Background: PubMed 23838361Konig 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.
- Background: PubMed 27494305Donath 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.
- Background: PubMed 1991946Podsiadlo 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.
- Background: PubMed 22587624Hellstrom 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.
- Background: PubMed 23975646Toma 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Lundin, PhD study director
Neurology department, Linköping University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Normal Pressure Hydrocephalus, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number). (time frame: Change from baseline to 3 month follow-up for patients. Once for HI.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795089, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.