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Completed

NCT Number: NCT04992910

Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute Stroke: a Pilot Randomised Controlled Trial

The purpose of this study is to evaluate the feasibility, usability, and safety of multi-field FES-assisted therapy for hand rehabilitation in individuals with subacute stroke. A secondary, exploratory objective is to estimate preliminary effect sizes for distal upper-limb motor outcomes to inform the design of future adequately powered trials.

Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb.

* Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation) * Control group - patients will receive standard care.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Paresis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
  • Unilateral paresis
  • Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment

Exclusion criteria

  • Very severe proximal spasticity: Ashworth > 3.
  • Psychiatric illness (including post-stroke depression).
  • Cognitive impairment.
  • Inability to provide informed consent.
  • Other severe medical problems.
  • Severe hemi-spatial neglect or anosognosia involving the affected arm.
  • Pacemakers
  • Pregnant women.
  • Skin ulcers.
  • Peripheral neuropathies.
  • Edema of the affected forearm and / or hand.
  • Severe pain.

Treatment and study plan

Functional electrical stimulation through medical device

Device

The patient will receive a therapy with functional electrical stimulation. For this, a device called "Fesia Grasp" will be used.

Duration: 80 min twice a week, for 6 weeks.

Standard therapy

Other

Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.

Primary outcomes

  1. Intrinsic Motivation Inventory (IMI)

    Time frame: 6 weeks

    This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'

  2. Adverse events

    Time frame: 6 weeks

    Any untoward medical occurrence during the clinical trial

  3. Usability questionnaire specifically designed for this study

    Time frame: 6 weeks

    It consists of a 5 item questionnaire with five response options (Likert sacle); from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients with the system and the therapy.

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: Baseline; 6 weeks; 3 months

    This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.

  2. Box & Blocks Test

    Time frame: Baseline; 6 weeks; 3 months

    It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.

    The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.

  3. Motor Activity Log (MAL)

    Time frame: Baseline; 6 weeks; 3 months

    Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).

  4. Fugl-Meyer Assessment (FMA) scale

    Time frame: 6 weeks

    It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Acronym: PI52021Rehab

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2021
Registry last updated
May 27, 2026

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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