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

L

Linköping University (LiU)

Status

Active, not recruiting

Conditions

Idiopathic Normal Pressure Hydrocephalus

Treatments

Procedure: Shunt surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04795089
2020-00719

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

102 participants in 2 patient groups

Patients
Description:
Patients with iNPH and shunt surgery.
Treatment:
Procedure: Shunt surgery
Healthy individuals
Description:
Healthy controls with similar gender and age distribution as the patients.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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