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

NCT ID: NCT04795089

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2024-07-31

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.

Conditions

Idiopathic Normal Pressure Hydrocephalus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients with iNPH and shunt surgery.

Shunt surgery

Intervention Type: PROCEDURE

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

Healthy individuals

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

No interventions assigned to this group

Interventions

Shunt surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• > 60 years of age
• Subjectively healthy without any serious disease

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fredrik Lundin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik Lundin, PhD

Role: STUDY_DIRECTOR

Neurology department, Linköping University Hospital

Locations

Neurology department, Linköping University Hospital

Linköping, , Sweden

Countries

Sweden

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Other Identifiers

2020-00719

Identifier Type: -

Identifier Source: org_study_id