Clinical trial NCT05679934: The Effects of Exercise on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus
Official title: The Effects of Home-Based Exercise Program And Telerehabilitation on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus Applied With Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NPH (Normal Pressure Hydrocephalus)
Keywords: balance
gait
performance
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to investigate effect of exercise program on balance, gait and performance in patients with normal pressure hydrocephalus applied with lumbar puncture. The main question it aims to answer are:

* Home based exercise program effective on balance, gait and performance
* Telerehabilitation exercise program effective on balance, gait and performance Researchers will compare home based exercise group, telerehabilitation group and control group to see if difference in terms of balance, gait and performance


Eligibility criteria: Inclusion Criteria:

* Age 60-90 years old
* Fulfilling the following clinical criteria for iNPH, as proposed by the Relkin and colleagues
* Able to walk independently (without physical assistance from a person and/or a device)

Exclusion Criteria:

* Patients who had severe physical disability or immobility, major primary psychiatric disorders (eg, schizophrenia, bipolar disorder), unstable major medical illnesses (eg, acute coronary syndrome, respiratory failure), acute cerebrovascular disease, severe visual or hearing impairments were excluded.
* Patients with diagnosis of seconder normal pressure hydrocephalus were also excluded.

Primary outcomes:
measure: Postural Stability
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Fall Risk
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Modified Clinical Test of Sensory Integration of Balance
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Walking Speed
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Cadence
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Stride Length
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Time Up and Go Test
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Functional Independence Measure
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Muscle Strength
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Secondary outcomes:
measure: Mini-mental state
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Clinical Dementia Rating
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Geriatric Depression Scale
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Barthel scale
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Lawton-Brody Instrumental Activities of Daily Living (iADL)
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Tinetti-test
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: The Nine-Hole Peg Test
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Grip strength
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: Fried frailty scale
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
measure: FRAIL scale
timeFrame: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
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