StrokeAPS-PILOTNCT06575140
Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery
A study testing Associative Peripheral Stimulation (APS) 1.0 and Peripheral Neuromuscular Stimulation in people with Stroke and Stroke, Acute, run by Ahmed A. Rahim at 3 sites in Mexico.
Trial summary
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Associative Peripheral Stimulation (APS) 1.0 and Peripheral Neuromuscular Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesMexico
- Study dates
- 18 Dec 2021to Dec 2024
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
- Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
- Ability to comprehend and follow study instructions;
- Ability to initiate finger extension (≥3°) at least three times per minute;
- Fugl-Meyer Assessment (Upper Extremity) score of <47.
Who cannot join
- Contraindications, intolerance, or high sensitivity to the experimental protocol;
- History of upper-extremity disability prior to the index stroke;
- Neurological conditions (other than stroke) affecting motor function;
- Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
- Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites, 3 recruiting
- Recruiting
General Hospital of Mexico
Mexico City
Claudia Elisa Alfaro Tapia, MD
- Recruiting
La Raza National Medical Center
Mexico City
Jonathan Isaí Colín Luna, MD
- Recruiting
National Institute of Neurology & Neurosurgery
Mexico City
Daniel San Juan Orta, MD
About this study
Official title: Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Hemorrhagic, Hemiparesis, Hemiparesis;Poststroke/CVA
- Being tested
- Associative Peripheral Stimulation (APS) 1.0, Peripheral Neuromuscular Stimulation
- Keywords
- Stroke Rehabilitation, Associative Peripheral Stimulation
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Associative Peripheral Stimulation (APS) 1.0Device
Associative peripheral stimulation paired with rehabilitative exercises.
Peripheral Neuromuscular StimulationDevice
Random peripheral stimulation paired with rehabilitative exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment Receives: Device: Associative Peripheral Stimulation (APS) 1.0 |
| Group B | Active comparator | Control Receives: Device: Peripheral Neuromuscular Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Average of Range of Motion (ROM)
Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.
Measured: 5 weeks
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.
Measured: 5 weeks
Secondary outcomes (4)
Maximum Average of Range of Motion (ROM)
Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.
Measured: 3 months
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.
Measured: 3 months
Action Research Arm Test (ARAT)
Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.
Measured: 5 weeks
Action Research Arm Test (ARAT)
Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start18 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed A. Rahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed A. Rahim, APS Trial Group
- Investigators
- Daniel San Juan Orta, MD, Study director, National Institute of Neurology & Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575140
- Sponsor's protocol ID
- APS-PILOT
- Acronym
- APS-PILOT
- Status last verified
- Aug 2024
- First submitted
- 24 Mar 2019
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data shall not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery
- ClinicalTrials.gov ID
- NCT06575140
- Acronym / sponsor ID
- APS-PILOT / APS-PILOT
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Hemorrhagic, Hemiparesis, Hemiparesis;Poststroke/CVA
- Keywords
- Stroke Rehabilitation, Associative Peripheral Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ahmed A. RahimUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Aug 2024 (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.
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Associative Peripheral Stimulation (APS) 1.0Treatment |
| Group B | Active comparator | Device: Peripheral Neuromuscular StimulationControl |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
- Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
- Ability to comprehend and follow study instructions;
- Ability to initiate finger extension (≥3°) at least three times per minute;
- Fugl-Meyer Assessment (Upper Extremity) score of <47.
Key exclusion criteria (5 listed)
- Contraindications, intolerance, or high sensitivity to the experimental protocol;
- History of upper-extremity disability prior to the index stroke;
- Neurological conditions (other than stroke) affecting motor function;
- Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
- Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.
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 |
|---|---|---|
| Associative Peripheral Stimulation (APS) 1.0Associative peripheral stimulation paired with rehabilitative exercises. | Device | Group A |
| Peripheral Neuromuscular StimulationRandom peripheral stimulation paired with rehabilitative exercises. | Device | Group B |
Primary outcome
Maximum Average of Range of Motion (ROM)
Time frame: 5 weeks
Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
Time frame: 5 weeks
Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.
4 secondary outcomes
Maximum Average of Range of Motion (ROM)
Time frame: 3 months
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
Time frame: 3 months
Action Research Arm Test (ARAT)
Time frame: 5 weeks
Action Research Arm Test (ARAT)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No. Individual participant data shall not be made available to other researchers.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Daniel San Juan Orta, MD study director
National Institute of Neurology & Neurosurgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Associative Peripheral Stimulation (APS) 1.0 and Peripheral Neuromuscular Stimulation in people with Stroke and Stroke, Acute, run by Ahmed A. Rahim at 3 sites in Mexico.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Rahim, MTM (+1 (916) 825-8792, ahmed.rahim@alumni.ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Average of Range of Motion (ROM) (time frame: 5 weeks). 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 30 Aug 2024.