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)

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* 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.