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Completed

NCT Number: NCT02579291

Dry Needling in Patients Who Had Experience Stroke

Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First-ever unilateral stroke;
  • hemiplegia resulting from stroke;
  • unilateral equinovarus gait with independent walk;
  • able to ambulate without supporting devices

Exclusion criteria

  • recurrent stroke;
  • previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
  • not independent in the basic activities of daily living
  • cognitive deficits;
  • progressive or severe neurologic diseases;
  • fear to needles;
  • any contraindication for dry needling

Treatment and study plan

dry needling

Other

Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.

Bobath

Other

Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity

Primary outcomes

  1. Changes in spasticity before and 10 minutes after the intervention

    Time frame: Baseline and immediate after the intervention

    Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4.

Secondary outcomes

  1. Changes in motor function before and 10 minutes after the intervention

    Time frame: Baseline and immediate after the intervention

    The Fugl-Meyer evaluation will be used to determine motor impairments and physical recovery of patients who had experienced a stroke

  2. Changes in stabilometry outcomes before and 10 minutes after the intervention

    Time frame: Baseline and immediate after the intervention

    The time reaction will be assessed as stabilometric data from each patient.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Changes in Spasticity, Motor Function and Stabilometry After Dry Needling of the Tibialis Posterior Muscle in Post-stroke Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2015
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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