Recruiting

Cupping

Sponsor:

Scott Getsoian

Code:

NCT06653855

Conditions

Stroke Gait Rehabilitation

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Dry Static Cupping

Placebo cupping

Standard physical therapy treatment

Study Details

Brief summary:

Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.

Conditions

Stroke Gait Rehabilitation

Study ID

NCT06653855

Start date

Dec, 2024

Status verified date

Oct, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 30-80
  • Acute stroke (within 6 months of stroke), with spasticity \& hemiparesis of LE
  • Referred by doctor for rehabilitation for a stroke-related condition
  • Attending Ascension Rehabilitation of Joliet for rehabilitation
  • Able to read or verbally understand English or Spanish

Exclusion Criteria:

  • Absent sensation of the areas to be cupped
  • Significant cognitive impairment
  • Pregnancy
  • Prescription anticoagulant medications
  • Blood clotting disorder
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Open wounds within the cupping area
  • Current DVT
  • Hematoma over the cupping area
  • Fracture over the cupping area
  • Active cancer within the cupping area
  • Current use of Baclofen
  • Current use of Botox
  • Current use of an anti-spasticity medication

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cupping group

This group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment.

sham comparator: Placebo cupping group

This group (arm) will receive a placebo-form of cupping (low, and non-therapeutic pressure amount in the cups), along with the standard physical therapy treatment.

Interventions

Dry Static Cupping

A myofascial decompression cupping set with a precision pressure pump will be used to perform dry static cupping to the adductor and hamstring muscle groups of the affected limb, using a negative pressure of 300mmHg for eight minutes each.

Placebo cupping

The same protocol will be used as stated for the Dry static cupping intervention, with the only difference being that the cup will be pumped to 50mmHg instead of 300mmHg.

Standard physical therapy treatment

Treatment will consist of typical physical therapy interventions performed for patients with spasticity of the lower extremity after stroke. These may include, but not be limited to:

  • Balance exercise
  • Therapeutic exercise
  • Neuromuscular/muscular coordination exercise
  • Manual (hands on) therapy
  • Gait training

The treating physical therapist is left with the autonomy of the standard physical therapy treatment (within the above stated groups of interventions) because patients with the diagnosis of stroke do not all present with the same type or level of impairment. Furthermore co-morbidities (e.g., hypertension) and/or functional level (wheelchair bound vs. independent ambulator) may necessitate different treatment strategies. Therefore, while the general categories of treatment will remain the same across all study patients, it is expected that the treating physical therapist provides patient-specific interventions.

Primary outcome measure

  • Modified Ashworth Scale [ Time Frame: At enrollment and then at 1, 2, and 3 months of treatment. ]

Central Contacts and Locations

Locations

Ascension Rehabilitation of Joliet

Recruiting

Joliet, Illinois, United States, 60435

Contacts

More Information

Sponsor

Scott Getsoian

Last update posted

Dec 13, 2024

Last verified

Oct, 2024

Keywords

  • Cupping
  • Spasticity
  • stroke
  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Scott Getsoian on 2024-12-13.