Back to resultsEffectiveness of Powerball System in People With Multiple Sclerosis (EMPOW)
Primary Purpose
Neurologic Disorder, Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
NDS-Powerball®,
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neurologic Disorder
Eligibility Criteria
Inclusion Criteria: Age between 20 and 60 years Diagnosed with MS according to McDonald criteria with an evolution time of more than two years Evaluation in the Kurtzke Disability Status Scale in Multiple Sclerosis (EDSS) with a score between 3.5 and 6 Score less than or equal to 4 on the "Pyramidal Function" section of the EDSS functional scale Stable medical treatment for at least six months prior to surgery Muscle tone in the upper extremities no greater than 2 points on the modified Ashworth scale. Muscle balance equal to or greater than 3 in the upper extremity Absence of cognitive impairment with ability to understand instructions and score equal to or greater than 4 on the Minimental Test. Exclusion Criteria: Diagnosis of another neurological disease or musculoskeletal alteration other than MS Diagnosis of any cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study Having suffered an exacerbation or hospitalization in the last three months before starting the assessment protocol, or during the therapeutic intervention process. Having received treatment with botulinum toxin in the six months prior to the start of the study Presence of visual alterations not corrected by means of ocular devices.
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Powerball
Conventional treatment
Arm Description
Rehabilitation using the Powerball system
Rehabilitation by conventional treatment
Outcomes
Primary Outcome Measures
Isometric hand strength:
Measured through the JAMAR® fist dynamometer, which is a sealed hydraulic system with an adjustable space to adapt to the handgrip of each patient. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of handgrip strength. In turn, its test-retest and inter-rater reliability is excellent in different populations. The patient held the tool with the upper limb at 0º of abduction and rotation; elbow flexed at 90º and the forearm in neutral position; wrist between 0 and 15º of radial deviation; and performed a maximum grip for 3 seconds with his 5 fingers, quantifying the force exerted in kilograms. Three measurements were taken with each hand, always starting with the dominant hand; once the three measurements were taken, the mean of these was used.
Isometric pincer force
A Baseline Pinch Gauge® was used to assess pinch force. Three presses were performed with the maximum possible force for 3 seconds, alternating between the dominant and non-dominant hand; the force obtained is marked in kilograms by the dynamometer. Once the 3 results were obtained, the average of these was obtained.
Secondary Outcome Measures
Box and Block Test (BBT)
used to assess coordination and manual dexterity. The patient is seated with the tool, a wooden box divided into two identical halves inside which there are 150 cubes of 2.5 cm of wood of different colors, in front of his midline. The patient has to pass as many cubes as possible from one half of the box to the other in 60 seconds. The test is performed first with the dominant hand and then with the non-dominant hand. It is a standardized tool for the measurement of the gross function of the MMSS, having been validated by gender and age in healthy subjects, in turn, it shows a low ceiling and floor effect in people with MS. On the other hand, other psychometric properties such as test-retest reliability and minimum detectable change have been studied in other neurological pathologies, the former being excellent and the latter finding its cut-off point in 6 blocks.
Nine Hole Peg Test (NHPT)
this test was used to assess the function of the upper limbs, in particular fine motor skills of the hand. The tool is placed in front of the subject's midline, the subject has to insert the 9 pegs, one at a time, into the 9 holes of a board and then remove them, again one at a time, in the shortest possible time; first with the dominant hand, and then the non-dominant hand, the hand that is not being assessed can hold the board to provide stability. The score is the time in seconds required to insert and remove all the pins. It shows excellent test-retest, inter-rater and inter-rater reliability and adequate internal consistency. Scores above 0.27 seconds per pin indicate severe hand dysfunction. The minimum detectable change for the non-dominant hand is 7.46 seconds, while for the dominant hand it is 4.38 seconds. The standard error of measurement for the non-dominant hand is found to be 2.69 seconds, while for the dominant hand it is found to be 1.58 seconds
Abilhand test
is a self-completed questionnaire to assess the manual dexterity of the person, defining this as the ability to perform a series of tasks, regardless of the strategies applied to achieve it. It was originally developed for people with rheumatoid arthritis, and has subsequently been validated for different pathologies. The questionnaire contains 23 items, which correspond to various tasks of ADLs, the patient will mark the degree of difficulty he/she refers to when performing the activities, with 4 possible answers, "impossible", "difficult", "easy" and "not applicable", giving a score of 0, 1 and 2 points respectively, those activities that have not been performed in a period greater than or equal to 3 months will be not applicable. The score can range from 0 to 46 points, the higher the score, the better the manual dexterity. Its inter- and intra-rater reliability, internal consistency and construct validity are excellent.
Fatigue Severity Scale (FSS)
this is a self-applied scale that assesses the appearance of fatigue in the patient when performing certain daily activities. It has 9 items whose weighting ranges from 1 to 7, with 1 point being "completely disagree" and 7 points "completely agree". The minimum score is 9 points and the maximum score is 63. A higher score determines that fatigue interferes more with the patient's life. The standard error of measurement is 0.7 points. The minimum detectable change is 1.9 points. The test-retest reliability is moderate, and the construct validity is excellent for people with MS.
Multiple Sclerosis Impact Scale (MSIS-29)
is a self-applied scale on the impact of the disease on the patient's life in the two weeks prior to performing. It presents 29 questions of which 20 assess the physical aspects of MS and 9 assess the psychosocial aspects. There are 5 possible answers that score from 1 to 5 from least to most impact of the disease. Two total scores are generated corresponding to the physical and psychological impact subscales. The scoring range is from 0 to 100, with a higher score indicating a greater degree of disability. It was designed to be a scientifically rigorous, clinically useful and disease-specific instrument. The physical sphere has been proven to have high internal consistency and good construct validity, while the cognitive sphere has good internal consistency. Low ceiling and floor effects and an excellent Cobranch's Alpha for both parts of the scale and a strong correlation between both parts of the scale
Customer Satisfaction Questionnaire (CSQ8)
8-item questionnaire on the opinion of the attention or service perceived during the study. The score ranges from 1 to 4, these scores being "bad", "fair", "good" and "excellent". The higher the score, the greater the degree of satisfaction with the service
Likert satisfaction questionnaire for the experimental group
at the end of the study, the participants in the experimental group also completed a satisfaction survey in relation to the experimental treatment carried out, using a Likert-type questionnaire prepared by the research team. This was a 20-item questionnaire on user satisfaction with the system used, ranging from attributes of the tool itself, ease of use or accessibility; design of the sessions, schedules, duration; as well as attributes of the center and physiotherapist involved in the intervention. The scores ranged from 1 to 5 points, with 1 point being "dissatisfied", 2 "not very satisfied", 3 "indifferent", 4 "satisfied", 5 "very satisfied".
Full Information
NCT ID
NCT05895734
First Posted
May 25, 2023
Last Updated
July 13, 2023
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT05895734
Brief Title
Effectiveness of Powerball System in People With Multiple Sclerosis
Acronym
EMPOW
Official Title
Effectiveness of Upper Limb Rehabilitation Using the Powerball System in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is a high percentage of impairment in the upper limbs (UL) in patients with multiple sclerosis (MS), being muscle strength and hand dexterity a determining factor for the preservation of functional activities, constituting the basis of independence and quality of life. The aim of this study is to determine the effects of a training protocol on UL muscle strength, through the NDS-Powerball® system, in combination with conventional physiotherapy, during 8 weeks in terms of muscle strength, coordination, fatigue, functionality and quality of life in people with MS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Disorder, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Powerball
Arm Type
Experimental
Arm Description
Rehabilitation using the Powerball system
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Rehabilitation by conventional treatment
Intervention Type
Device
Intervention Name(s)
NDS-Powerball®,
Intervention Description
Rehabilitation using the Powerball system
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Rehabilitation by conventional treatment
Primary Outcome Measure Information:
Title
Isometric hand strength:
Description
Measured through the JAMAR® fist dynamometer, which is a sealed hydraulic system with an adjustable space to adapt to the handgrip of each patient. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of handgrip strength. In turn, its test-retest and inter-rater reliability is excellent in different populations. The patient held the tool with the upper limb at 0º of abduction and rotation; elbow flexed at 90º and the forearm in neutral position; wrist between 0 and 15º of radial deviation; and performed a maximum grip for 3 seconds with his 5 fingers, quantifying the force exerted in kilograms. Three measurements were taken with each hand, always starting with the dominant hand; once the three measurements were taken, the mean of these was used.
Time Frame
1 minute
Title
Isometric pincer force
Description
A Baseline Pinch Gauge® was used to assess pinch force. Three presses were performed with the maximum possible force for 3 seconds, alternating between the dominant and non-dominant hand; the force obtained is marked in kilograms by the dynamometer. Once the 3 results were obtained, the average of these was obtained.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Box and Block Test (BBT)
Description
used to assess coordination and manual dexterity. The patient is seated with the tool, a wooden box divided into two identical halves inside which there are 150 cubes of 2.5 cm of wood of different colors, in front of his midline. The patient has to pass as many cubes as possible from one half of the box to the other in 60 seconds. The test is performed first with the dominant hand and then with the non-dominant hand. It is a standardized tool for the measurement of the gross function of the MMSS, having been validated by gender and age in healthy subjects, in turn, it shows a low ceiling and floor effect in people with MS. On the other hand, other psychometric properties such as test-retest reliability and minimum detectable change have been studied in other neurological pathologies, the former being excellent and the latter finding its cut-off point in 6 blocks.
Time Frame
3 minutes
Title
Nine Hole Peg Test (NHPT)
Description
this test was used to assess the function of the upper limbs, in particular fine motor skills of the hand. The tool is placed in front of the subject's midline, the subject has to insert the 9 pegs, one at a time, into the 9 holes of a board and then remove them, again one at a time, in the shortest possible time; first with the dominant hand, and then the non-dominant hand, the hand that is not being assessed can hold the board to provide stability. The score is the time in seconds required to insert and remove all the pins. It shows excellent test-retest, inter-rater and inter-rater reliability and adequate internal consistency. Scores above 0.27 seconds per pin indicate severe hand dysfunction. The minimum detectable change for the non-dominant hand is 7.46 seconds, while for the dominant hand it is 4.38 seconds. The standard error of measurement for the non-dominant hand is found to be 2.69 seconds, while for the dominant hand it is found to be 1.58 seconds
Time Frame
2 minutes
Title
Abilhand test
Description
is a self-completed questionnaire to assess the manual dexterity of the person, defining this as the ability to perform a series of tasks, regardless of the strategies applied to achieve it. It was originally developed for people with rheumatoid arthritis, and has subsequently been validated for different pathologies. The questionnaire contains 23 items, which correspond to various tasks of ADLs, the patient will mark the degree of difficulty he/she refers to when performing the activities, with 4 possible answers, "impossible", "difficult", "easy" and "not applicable", giving a score of 0, 1 and 2 points respectively, those activities that have not been performed in a period greater than or equal to 3 months will be not applicable. The score can range from 0 to 46 points, the higher the score, the better the manual dexterity. Its inter- and intra-rater reliability, internal consistency and construct validity are excellent.
Time Frame
3 minutes
Title
Fatigue Severity Scale (FSS)
Description
this is a self-applied scale that assesses the appearance of fatigue in the patient when performing certain daily activities. It has 9 items whose weighting ranges from 1 to 7, with 1 point being "completely disagree" and 7 points "completely agree". The minimum score is 9 points and the maximum score is 63. A higher score determines that fatigue interferes more with the patient's life. The standard error of measurement is 0.7 points. The minimum detectable change is 1.9 points. The test-retest reliability is moderate, and the construct validity is excellent for people with MS.
Time Frame
2 minutes
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
is a self-applied scale on the impact of the disease on the patient's life in the two weeks prior to performing. It presents 29 questions of which 20 assess the physical aspects of MS and 9 assess the psychosocial aspects. There are 5 possible answers that score from 1 to 5 from least to most impact of the disease. Two total scores are generated corresponding to the physical and psychological impact subscales. The scoring range is from 0 to 100, with a higher score indicating a greater degree of disability. It was designed to be a scientifically rigorous, clinically useful and disease-specific instrument. The physical sphere has been proven to have high internal consistency and good construct validity, while the cognitive sphere has good internal consistency. Low ceiling and floor effects and an excellent Cobranch's Alpha for both parts of the scale and a strong correlation between both parts of the scale
Time Frame
3 minutes
Title
Customer Satisfaction Questionnaire (CSQ8)
Description
8-item questionnaire on the opinion of the attention or service perceived during the study. The score ranges from 1 to 4, these scores being "bad", "fair", "good" and "excellent". The higher the score, the greater the degree of satisfaction with the service
Time Frame
2 minutes
Title
Likert satisfaction questionnaire for the experimental group
Description
at the end of the study, the participants in the experimental group also completed a satisfaction survey in relation to the experimental treatment carried out, using a Likert-type questionnaire prepared by the research team. This was a 20-item questionnaire on user satisfaction with the system used, ranging from attributes of the tool itself, ease of use or accessibility; design of the sessions, schedules, duration; as well as attributes of the center and physiotherapist involved in the intervention. The scores ranged from 1 to 5 points, with 1 point being "dissatisfied", 2 "not very satisfied", 3 "indifferent", 4 "satisfied", 5 "very satisfied".
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20 and 60 years
Diagnosed with MS according to McDonald criteria with an evolution time of more than two years
Evaluation in the Kurtzke Disability Status Scale in Multiple Sclerosis (EDSS) with a score between 3.5 and 6
Score less than or equal to 4 on the "Pyramidal Function" section of the EDSS functional scale
Stable medical treatment for at least six months prior to surgery
Muscle tone in the upper extremities no greater than 2 points on the modified Ashworth scale.
Muscle balance equal to or greater than 3 in the upper extremity
Absence of cognitive impairment with ability to understand instructions and score equal to or greater than 4 on the Minimental Test.
Exclusion Criteria:
Diagnosis of another neurological disease or musculoskeletal alteration other than MS
Diagnosis of any cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study
Having suffered an exacerbation or hospitalization in the last three months before starting the assessment protocol, or during the therapeutic intervention process.
Having received treatment with botulinum toxin in the six months prior to the start of the study
Presence of visual alterations not corrected by means of ocular devices.
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Effectiveness of Powerball System in People With Multiple Sclerosis
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