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

Active, not recruiting

• Conditions: Idiopathic Normal Pressure Hydrocephalus
• Interventions: Procedure: Shunt surgery

• Registration Number: NCT04795089
• Lead Sponsor: Linkoeping University

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.

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 Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-03-10
• Study Start: 2021-03-11
• Study First Posted: 2021-03-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Shunt surgery	Patients with iNPH and shunt surgery.

Primary Outcome Measures

Name	Time	Method
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).	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)	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)	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)	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)	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	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.
Rating of global change assessed with the Global Rating of Change Scale	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.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Heel strike and Toe of angle (angle degree)	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)	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)	Change from baseline to 3 month follow-up for patients. Once for HI.	Measurement in part 1. Mobile gait analysis system.
Mobility, walking ability and balance assessed with the Timed up and Go test	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.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed distance (m)	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)	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)	Change from baseline to 3 month follow-up for patients. Once for HI.	Measurement in part 1. Mobile gait analysis system.
Sense of Coherence assessed with the 29 item Orientation to life questionnaire - swedish version (KASAM questionnaire)	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	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	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.

Trial Locations

Locations (1)

Neurology department, Linköping University Hospital; 🇸🇪 Linköping, Sweden