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Hemiplegia and HemiparesisNCT04652934

Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury

A study testing Neurodynamic and Mimic group in people with Hemiplegia and Hemiparesis and Acquired Brain Injury, run by Vanesa Abuín 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
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Trial summary

The main objective: To determine changes in physiological and structural properties of upper limb muscles with spasticity in patients with acquired brain injury after applying neural mobilization improving their functional performance, their participation in society and quality of life. Read more about this study

Who is it for?
Ages 25 to 50 years
What is being tested?
Neurodynamic and Mimic group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteSpain
Study dates
26 Jan 2022to 28 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 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of acquired brain injury (hemiplegia-hemiparesis)
  • Ages between 25 and 50 years

Who cannot join

  • Unable to understand and respond to verbal instructions
  • Absence of voluntary movement in the upper limb
  • Take medicine for spasticity
  • Botulinum toxin infiltration in the last 6 months

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Federico Salniccia

    Madrid, 28670

Other trials in Spain

About this study

Official title: Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury: Randomized, Controlled, Multi-Centric, Single-Blind Clinical Trial

The main objective:

To determine changes in physiological and structural properties of upper limb muscles with spasticity in patients with acquired brain injury after applying neural mobilization improving their functional performance, their participation in society and quality of life.

Hypothesis:

Peripheral nerve mobilizations performed with neurodynamic techniques in upper limb in patients with acquired brain injury, generate changes at structural and physiological level, favoring the performance of daily life activities and improving the quality of life.

Read the detailed description

Randomized clinical trial with blinding of the subject, the evaluator and the person analyzing the data.

In the experimental group will be performed neural mobilitazion technique, while in the sham a technique to mimic neurodynamic.

The assessment will be made by a single evaluator.

Being tested
Neurodynamic, Mimic group
Keywords
Acquired Brain Injury, Hemiplegia, Neural Mobilization, Upper limb
Medical subject headings
Hemiplegia, Paresis, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurodynamicOther

    The Upper Limb Neurodynamic Test (ULNT1) technique described by Butler will be performed on the affected limb. This technique consists of performing shoulder depression, 90º shoulder abduction, hand, wrist and forearm in a neutral position, external rotation of the shoulder and extension of the elbow. After positioning the limb in this position, wrist flexion-extension movements will be performed smoothly and rhythmically of 20 movements every minute, for 3 minutes, three times per session with 1 minute of rest between each series.

  • Mimic groupOther

    The protocol used by Beneciuk et al. Will be used. This intervention consists of imitating NM without stressing the nervous system. It will be carried out as follow: a neutral cervical position will be maintained (0º of cervical inclination), 45º of shoulder abduction without depression, 45º of external rotation of the shoulder combined with 45º of elbow flexion with the forearm in pronation. Afterwards, 10 wrist flexion-extension movements will be performed at a rate of 6 seconds per cycle (3 seconds of flexion and 3 seconds of extension). The resistance that you will feel will stabilize when you change motion. Once the 10 cycles of movements have been carried out, a wrist flexion will be maintained for 10 seconds.

Study groups in NCT04652934
Study groupRoleWhat they receive
Intervention groupExperimentalThe Upper Limb Neurodynamic Test (ULNT1) technique described by Butler will be performed on the affected limb. This technique consists of performing shoulder depression, 90º shoulder abduction, hand, wrist and forearm in a neutral position, external rotation of the shoulder and extension of the elbow. After positioning the limb in this position, wrist flexion-extension movements will be performed smoothly and rhythmically of 20 movements every minute, for 3 minutes, three times per session with 1 minute of rest between each series.
Receives: Other: Neurodynamic
Mimic groupSham comparatorThe protocol used by Beneciuk et al. Will be used. This intervention consists of imitating NM without stressing the nervous system. It will be carried out as follow: a neutral cervical position will be maintained (0º of cervical inclination), 45º of shoulder abduction without depression, 45º of external rotation of the shoulder combined with 45º of elbow flexion with the forearm in pronation. Afterwards, 10 wrist flexion-extension movements will be performed at a rate of 6 seconds per cycle (3 seconds of flexion and 3 seconds of extension). The resistance that you will feel will stabilize when you change motion. Once the 10 cycles of movements have been carried out, a wrist flexion will be maintained for 10 seconds.
Receives: Other: Mimic group

What is being measured

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

  1. Changes in Manual Ability

    Abilhand Scale; Score 0(worse outcome)-2(better outcome)

    Measured: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

  2. Changes in Muscle Spasticity

    MAS (Modified Ashworth Scale) 0 (better outcome) - 4 (worse outcome)

    Measured: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

  3. Changes in Muscle Strength

    Dynamometer

    Measured: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

  4. Changes in Nervous Conduction

    Delsys Trigno Avanti (surface eMG for non-invasive assessment of muscles)

    Measured: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

  5. Changes in Upper Limb Pain Perception

    EVA (Visual Analog Scale) 0 (worse outcome) - 10 (better outcome)

    Measured: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

  6. Changes in Upper Limb Pain to Pressure

    Algometer

    Measured: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start26 Jan 2022
  3. Primary completion28 Jul 2023
  4. Study completion28 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
Model description
Randomized Controlled Trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652934
Sponsor's protocol ID
HUFA CEIC 20/154
Status last verified
Jul 2023
First submitted
8 Oct 2020
Last updated
1 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • The World Health report 1996--fighting disease, fostering development. World Health Forum. 1997;18(1):1-8.

    PubMed 9233055
  • Synnot A, Chau M, Pitt V, O'Connor D, Gruen RL, Wasiak J, Clavisi O, Pattuwage L, Phillips K. Interventions for managing skeletal muscle spasticity following traumatic brain injury. Cochrane Database Syst Rev. 2017 Nov 22;11(11):CD008929. doi: 10.1002/14651858.CD008929.pub2.

    PubMed 29165784
  • Basson A, Olivier B, Ellis R, Coppieters M, Stewart A, Mudzi W. The Effectiveness of Neural Mobilization for Neuromusculoskeletal Conditions: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Sep;47(9):593-615. doi: 10.2519/jospt.2017.7117. Epub 2017 Jul 13.

    PubMed 28704626
  • Martins C, Pereira R, Fernandes I, Martins J, Lopes T, Ramos L, Pacheco J, Silva AG. Neural gliding and neural tensioning differently impact flexibility, heat and pressure pain thresholds in asymptomatic subjects: A randomized, parallel and double-blind study. Phys Ther Sport. 2019 Mar;36:101-109. doi: 10.1016/j.ptsp.2019.01.008. Epub 2019 Jan 23.

    PubMed 30710858
  • Beltran-Alacreu H, Jimenez-Sanz L, Fernandez Carnero J, La Touche R. Comparison of Hypoalgesic Effects of Neural Stretching vs Neural Gliding: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2015 Nov-Dec;38(9):644-652. doi: 10.1016/j.jmpt.2015.09.002. Epub 2015 Oct 23.

    PubMed 26481666
  • Almeida RS, Machado E, Yamato TP, Santos De Melo L, Nogueira LAC. Pragmatic neural tissue management improves short-term pain and disability in patients with sciatica: a single-arm clinical trial. J Man Manip Ther. 2019 Sep;27(4):208-214. doi: 10.1080/10669817.2019.1580420. Epub 2019 Feb 26.

    PubMed 30935325
  • Ayub A, Osama M, Ahmad S. Effects of active versus passive upper extremity neural mobilization combined with mechanical traction and joint mobilization in females with cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(5):725-730. doi: 10.3233/BMR-170887.

    PubMed 30664500
  • Kim DG, Chung SH, Jung HB. The effects of neural mobilization on cervical radiculopathy patients' pain, disability, ROM, and deep flexor endurance. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):951-959. doi: 10.3233/BMR-140191.

    PubMed 28453446
  • Ferragut-Garcias A, Plaza-Manzano G, Rodriguez-Blanco C, Velasco-Roldan O, Pecos-Martin D, Oliva-Pascual-Vaca J, Llabres-Bennasar B, Oliva-Pascual-Vaca A. Effectiveness of a Treatment Involving Soft Tissue Techniques and/or Neural Mobilization Techniques in the Management of Tension-Type Headache: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):211-219.e2. doi: 10.1016/j.apmr.2016.08.466. Epub 2016 Sep 10.

    PubMed 27623523
  • Sanz DR, Solano FU, Lopez DL, Corbalan IS, Morales CR, Lobo CC. Effectiveness of median nerve neural mobilization versus oral ibuprofen treatment in subjects who suffer from cervicobrachial pain: a randomized clinical trial. Arch Med Sci. 2018 Jun;14(4):871-879. doi: 10.5114/aoms.2017.70328. Epub 2017 Sep 26.

    PubMed 30002707
  • Rodriguez-Sanz D, Calvo-Lobo C, Unda-Solano F, Sanz-Corbalan I, Romero-Morales C, Lopez-Lopez D. Cervical Lateral Glide Neural Mobilization Is Effective in Treating Cervicobrachial Pain: A Randomized Waiting List Controlled Clinical Trial. Pain Med. 2017 Dec 1;18(12):2492-2503. doi: 10.1093/pm/pnx011.

    PubMed 28340157
  • Rodriguez-Sanz D, Lopez-Lopez D, Unda-Solano F, Romero-Morales C, Sanz-Corbalan I, Beltran-Alacreu H, Calvo-Lobo C. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-Controlled Clinical Trial. Pain Pract. 2018 Apr;18(4):431-442. doi: 10.1111/papr.12614. Epub 2017 Nov 20.

    PubMed 28734105
  • Arumugam V, Selvam S, MacDermid JC. Radial nerve mobilization reduces lateral elbow pain and provides short-term relief in computer users. Open Orthop J. 2014 Oct 17;8:368-71. doi: 10.2174/1874325001408010368. eCollection 2014.

    PubMed 25352930
  • Lau YN, Ng J, Lee SY, Li LC, Kwan CM, Fan SM, Leung BPL, Lo CN. A brief report on the clinical trial on neural mobilization exercise for joint pain in patients with rheumatoid arthritis. Z Rheumatol. 2019 Jun;78(5):474-478. doi: 10.1007/s00393-018-0521-7.

    PubMed 30112581
  • Villafane JH, Cleland JA, Fernandez-de-Las-Penas C. The effectiveness of a manual therapy and exercise protocol in patients with thumb carpometacarpal osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2013 Apr;43(4):204-13. doi: 10.2519/jospt.2013.4524. Epub 2013 Mar 13.

    PubMed 23485660

Questions about this trial

What is this clinical trial studying?

A study testing Neurodynamic and Mimic group in people with Hemiplegia and Hemiparesis and Acquired Brain Injury, run by Vanesa Abuín 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 2 inclusion and 4 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 1 Aug 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. Some participants in this study may receive a placebo. 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?

Changes in Manual Ability (time frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04652934, which also lists 45 linked publications.

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 1 Aug 2023.

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