Neurologic DisorderEMPOWNCT05895734
Effectiveness of Powerball System in People With Multiple Sclerosis
A study testing NDS-Powerball®, and Conventional treatment in people with Neurologic Disorder and Multiple Sclerosis, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Neurologic Disorder, Multiple Sclerosis
- What is being tested?
- NDS-Powerball®, and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2023to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Upper Limb Rehabilitation Using the Powerball System in People With Multiple Sclerosis
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.
- Conditions
- Neurologic Disorder, Multiple Sclerosis
- Being tested
- NDS-Powerball®,, Conventional treatment
- Medical subject headings
- Nervous System Diseases, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDS-Powerball®,Device
Rehabilitation using the Powerball system
Conventional treatmentOther
Rehabilitation by conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Powerball | Experimental | Rehabilitation using the Powerball system Receives: Device: NDS-Powerball®, |
| Conventional treatment | Active comparator | Rehabilitation by conventional treatment Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
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.
Measured: 3 minutes
Secondary outcomes (7)
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.
Measured: 3 minutes
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
Measured: 2 minutes
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.
Measured: 3 minutes
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.
Measured: 2 minutes
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
Measured: 3 minutes
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
Measured: 2 minutes
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".
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start10 Jan 2023
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895734
- Sponsor's protocol ID
- EM_POWERBALL23
- Acronym
- EMPOW
- Status last verified
- Jul 2023
- First submitted
- 25 May 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Upper Limb Rehabilitation Using the Powerball System in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05895734
- Acronym / sponsor ID
- EMPOW / EM_POWERBALL23
- Conditions
- Neurologic Disorder, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powerball | Experimental | Device: NDS-Powerball®,Rehabilitation using the Powerball system |
| Conventional treatment | Active comparator | Other: Conventional treatmentRehabilitation by conventional treatment |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDS-Powerball®,Rehabilitation using the Powerball system | Device | Powerball |
| Conventional treatmentRehabilitation by conventional treatment | Other | Conventional treatment |
Primary outcome
Isometric hand strength:
Time frame: 1 minute
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
Time frame: 3 minutes
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.
7 secondary outcomes
Box and Block Test (BBT)
Time frame: 3 minutes
Nine Hole Peg Test (NHPT)
Time frame: 2 minutes
Abilhand test
Time frame: 3 minutes
Fatigue Severity Scale (FSS)
Time frame: 2 minutes
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 3 minutes
Customer Satisfaction Questionnaire (CSQ8)
Time frame: 2 minutes
Likert satisfaction questionnaire for the experimental group
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Yes
Related trials for Neurologic Disorder
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDS-Powerball®, and Conventional treatment in people with Neurologic Disorder and Multiple Sclerosis, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric hand strength: (time frame: 1 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.