AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Spain1 site
  • Universidad Rey Juan Carlos

    Alcorcón, Madrid, 28922

Other trials in Spain

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.

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 groups in NCT05895734
Study groupRoleWhat they receive
PowerballExperimentalRehabilitation using the Powerball system
Receives: Device: NDS-Powerball®,
Conventional treatmentActive comparatorRehabilitation by conventional treatment
Receives: Other: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted9 Jun 2023
  2. Study start10 Jan 2023
  3. Primary completion10 Jul 2023
  4. Study completion10 Jul 2023

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in