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The Effects of Exercise on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus

Primary Purpose

NPH (Normal Pressure Hydrocephalus)

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NPH (Normal Pressure Hydrocephalus) focused on measuring balance, gait, performance

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Home-Based Exercise

Telerehabilitation

Control Group

Arm Description

Patients who perform home-based exercise program

Patients who perform telerehabilitation exercise program

No intervention

Outcomes

Primary Outcome Measures

Postural Stability
Biodex Balance System was used to measure balance-related variables. Biodex has a fixable and movable platform and a touch screen on which the participant can visually track his/her movements.The Postural Stability test emphasizes a patient's ability to maintain center of balance. The device measures anterior-posterior (AP) and medial-lateral (ML) oscillations of the participant and provides anterior-posterior index, medial-lateral index and total stability index scores. Since these scores assess deviations from center, a lower score is more desirable than a higher score
Fall Risk
Biodex Balance System was used to measure balance-related variables.Fall Risk test measures the patient's postural sway velocity to predict risk. There is a circular platform that moves freely and simultaneously about the anterior-posterior and medial-lateral axes and provides overall stabiliy index score. The index of overall stability is measured in degrees and higher scores indicate poor dynamic balance
Modified Clinical Test of Sensory Integration of Balance
Biodex Balance System was used to measure balance-related variables. mCTSIB provides a generalized assessment of how well patient can integrate various senses with respect to balance and compensate when one or more of those senses are compromised. mCTSIB was performed in four different conditions: eyes open-firm surface (EO-firm), eyes closed-firm surface (EC-firm), eyes open-foam surface (EO- foam), eyes closed-foam surface (EC-foam). The device computes an overall sway index as the standard deviation of the recorded position away from the center. Higher sway index scores indicate greater deviations from the center, therefore, lower scores reflect better response
Walking Speed
The gait characteristics was measured using G-Walk sensor system. The BTS G-Walk (G-Sensor 2) is a portable, wireless, inertial system with wearable sensors. Each participant was asked to walk down a hallway through a central 7- meter "testing" zone, instructed to walk at his/her ordinary comfortable walking speed and return start line. The acquired data is transmitted via a Bluetooth connection to a computer and processed using the special software program BTS G-Studio.
Cadence
The test will perform with G-walk device.
Stride Length
The test will perform with G-walk device.
Time Up and Go Test
The test will perform with G-walk device.
The Functional Independence Measure
The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients.FIM is an 18-item, clinician reported scale that assesses an individuals functional capability in six areas including self-care, continence, mobility, transfers, communication and cognition.
Muscle Strength
We measured knee extensor and ankle dorsi flexor muscle strength using a hand-held dynamometer. Participants were asked to seat on a bedside (height 100 cm) with hip and knee at 90 degree flexion. Three measurements were taken for each muscle group and the highest score was recorded in kg.

Secondary Outcome Measures

Mini-mental state
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment
The Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.
The Clinical Dementia Rating
The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia
The Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly.
The Cornell Scale for Depression in Dementia (CSDD)
The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in demented patients.
The Barthel scale
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL).
The Lawton-Brody Instrumental Activities of Daily Living (iADL)
The Lawton-Brody Instrumental Activities of Daily Living (iADL) scale covers eight functional domains: using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances.
The Tinetti-test
The Tinetti-test, also called Performance-Oriented Mobility Assessment (POMA) assesses a person's perception of balance and stability during activities of daily living and their fear of falling.
The Nine-Hole Peg Test
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses
Grip strength
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength
Fried frailty scale
Fried frailty scale is the very first and most commonly used assessment scale for an operational definition of physical frailty with its demonstrated success as a predictor of mobility limitations and mortality. Fried frailty scale includes five components, among which three or more were defined as frailty: unintentional weight loss (10 lbs in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity.
FRAIL scale
FRAIL scale consists of 5 items; fatigue state, resistance, mobility, weight loss, and existing diseases.

Full Information

First Posted
December 17, 2022
Last Updated
December 24, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05679934
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NPH (Normal Pressure Hydrocephalus)
Keywords
balance, gait, performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-Based Exercise
Arm Type
Experimental
Arm Description
Patients who perform home-based exercise program
Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Patients who perform telerehabilitation exercise program
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Stretching and strengthening exercises will be applied to the participants
Primary Outcome Measure Information:
Title
Postural Stability
Description
Biodex Balance System was used to measure balance-related variables. Biodex has a fixable and movable platform and a touch screen on which the participant can visually track his/her movements.The Postural Stability test emphasizes a patient's ability to maintain center of balance. The device measures anterior-posterior (AP) and medial-lateral (ML) oscillations of the participant and provides anterior-posterior index, medial-lateral index and total stability index scores. Since these scores assess deviations from center, a lower score is more desirable than a higher score
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Fall Risk
Description
Biodex Balance System was used to measure balance-related variables.Fall Risk test measures the patient's postural sway velocity to predict risk. There is a circular platform that moves freely and simultaneously about the anterior-posterior and medial-lateral axes and provides overall stabiliy index score. The index of overall stability is measured in degrees and higher scores indicate poor dynamic balance
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Modified Clinical Test of Sensory Integration of Balance
Description
Biodex Balance System was used to measure balance-related variables. mCTSIB provides a generalized assessment of how well patient can integrate various senses with respect to balance and compensate when one or more of those senses are compromised. mCTSIB was performed in four different conditions: eyes open-firm surface (EO-firm), eyes closed-firm surface (EC-firm), eyes open-foam surface (EO- foam), eyes closed-foam surface (EC-foam). The device computes an overall sway index as the standard deviation of the recorded position away from the center. Higher sway index scores indicate greater deviations from the center, therefore, lower scores reflect better response
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Walking Speed
Description
The gait characteristics was measured using G-Walk sensor system. The BTS G-Walk (G-Sensor 2) is a portable, wireless, inertial system with wearable sensors. Each participant was asked to walk down a hallway through a central 7- meter "testing" zone, instructed to walk at his/her ordinary comfortable walking speed and return start line. The acquired data is transmitted via a Bluetooth connection to a computer and processed using the special software program BTS G-Studio.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Cadence
Description
The test will perform with G-walk device.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Stride Length
Description
The test will perform with G-walk device.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Time Up and Go Test
Description
The test will perform with G-walk device.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Functional Independence Measure
Description
The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients.FIM is an 18-item, clinician reported scale that assesses an individuals functional capability in six areas including self-care, continence, mobility, transfers, communication and cognition.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Muscle Strength
Description
We measured knee extensor and ankle dorsi flexor muscle strength using a hand-held dynamometer. Participants were asked to seat on a bedside (height 100 cm) with hip and knee at 90 degree flexion. Three measurements were taken for each muscle group and the highest score was recorded in kg.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Secondary Outcome Measure Information:
Title
Mini-mental state
Description
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Clinical Dementia Rating
Description
The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Geriatric Depression Scale
Description
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Cornell Scale for Depression in Dementia (CSDD)
Description
The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in demented patients.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Barthel scale
Description
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL).
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Lawton-Brody Instrumental Activities of Daily Living (iADL)
Description
The Lawton-Brody Instrumental Activities of Daily Living (iADL) scale covers eight functional domains: using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Tinetti-test
Description
The Tinetti-test, also called Performance-Oriented Mobility Assessment (POMA) assesses a person's perception of balance and stability during activities of daily living and their fear of falling.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
The Nine-Hole Peg Test
Description
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Grip strength
Description
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
Fried frailty scale
Description
Fried frailty scale is the very first and most commonly used assessment scale for an operational definition of physical frailty with its demonstrated success as a predictor of mobility limitations and mortality. Fried frailty scale includes five components, among which three or more were defined as frailty: unintentional weight loss (10 lbs in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Title
FRAIL scale
Description
FRAIL scale consists of 5 items; fatigue state, resistance, mobility, weight loss, and existing diseases.
Time Frame
Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ÜMİT YEŞİL
Phone
+905384834145
Email
fztumityesil@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
NİHAL GELECEK
Phone
+905055250323
Email
ngelecek71@gmail.com
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmet turan ışık, Prof.
Email
atisik@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nihal GELECEK, Prof.
First Name & Middle Initial & Last Name & Degree
Ahmet Turan IŞIK, Prof.
First Name & Middle Initial & Last Name & Degree
İlke KARA, Msc
First Name & Middle Initial & Last Name & Degree
Derya KAYA, MD
First Name & Middle Initial & Last Name & Degree
Açelya GÖKDENİZ YILDIRIM, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
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The Effects of Exercise on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus

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