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NCT Number: NCT06653855

The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Cupping is an ancient alternative medicine. A common form of cupping, called dry static cupping, involves creating negative pressure inside a therapeutic cup. The cup is then placed on the skin, creating a light suction effect. In Eastern Medicine, cupping has been used to treat a variety of diseases. More recently, in Western society, cupping has been used after injury, and among other effects, has been found to improve blood volume and tissue oxygenation to an area. These effects have originally been thought to be peripheral in nature, occurring at the cupping site, hence, why cupping has been used for treatment for conditions like carpal tunnel syndrome, spinal pain, knee osteoarthritis, and other musculoskeletal conditions.

However, a recent systematic review found cupping to be beneficial for rehabilitation after stroke. These conclusions raise the question of a possible mechanism for cupping to improve impairments related to the central nervous system, such as spasticity after stroke. However, many of the studies to date have serious methodological flaws that limit the direct causation of cupping to the reduction of spasticity. As well, the majority of studies only involve the upper extremity. No study has yet looked at the therapeutic effects of dry static cupping on lower extremity spasticity reduction after stroke.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dry Static Cupping

Other

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

Other

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

Other

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 outcomes

  1. Modified Ashworth Scale

    Time frame: At enrollment and then at 1, 2, and 3 months of treatment.

    The Modified Ashworth Scale measures spasticity on a 0-4 ordinal scale, with higher scores indicating greater spasticity. The grade is determined by passively moving a joint/muscle through a high velocity unidirectional quick stretch. For this study, spasticity will be assessed for the hip adductors and hamstrings of the affected side.

    Equipment:

    Mat Table

    Administration:

    Patient is positioned in supine on a mat table.

    For Hip Adduction: Physical therapist passively moves the affected lower extremity into hip abduction quickly keeping the knee in extension.

    For Hamstrings: Physical therapist passively moves the hip to 90 degrees of flexion and allows the knee to bend into knee flexion. Then, the therapist passively moves the affected knee into extension quickly.

Secondary outcomes

  1. Six-Minute Walk Test (6MWT)

    Time frame: At enrollment and then at 1, 2, and 3 months of treatment.

    The Six-minute Walk Test is a measure of aerobic capacity and gait. It is measured in feet on a ratio scale.

    Administration:

    The patient is instructed to walk down an unobstructed path for six minutes, while the physical therapist walks behind them with a stopwatch and rolling tape measure to monitor the time and steps of the patient during the test. The distance (in feet) that the patient walked, after six minutes, is used as the score for the test.

    To note: blood pressure will be taken before and after the test.

  2. Timed Up and Go (TUG) Test

    Time frame: At enrollment and then at 1, 2, and 3 months of treatment.

    The TUG assesses mobility, ability, and fall risk in older adults. It is measured in seconds, on a ratio scale.

    Equipment:

    • Chair with armrests
    • Stopwatch
    • Marker to designate 10' turn around point

    Administration:

    • The patient sits in the chair
    • On the command "ready and go" the patient gets up from the chair, walks 10 feet at a comfortable and safe pace, turns, walks back to the chair and sits down.
    • Timing begins at the instruction "go" and stops when the patient is seated
    • The patient must use the same assistive device for each assessment time, but is able to complete the test with multiple devices or no device.
    • The physical therapist will demonstrate the activity to the patient.
  3. Berg Balance Scale (BBS)

    Time frame: At enrollment and then at 1, 2, and 3 months of treatment.

    The Berg Balance Scale is a 14-item test that measures static balance and fall risk in adults. Each item is scored on a 0-4 ordinal scale. At conclusion of the 14 items, the score is tallied.

    Equipment: Chair with arms, Chair without arms, Mat, Stopwatch, Yardstick, Slipper/sandal, 7 ¾" step, Blind fold, Tape.

    Items (14):

    • sitting to standing
    • standing unsupported
    • sitting unsupported with feet on floor
    • standing to sitting
    • transfers
    • standing unsupported with eyes closed
    • standing unsupported with feet together
    • reaching forward with outstretched arm
    • pick up object from floor
    • turn to look behind over each shoulder
    • turning 360 degrees
    • dynamic weight shifting while standing unsupported
    • standing unsupported one foot in front
    • standing on one leg

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Nurczyk

CONTACT

[email protected]

815-741-7114

Scott Getsoian

CONTACT

[email protected]

815-735-9261

Sponsors and collaborators

Lead sponsor

Scott Getsoian

Industry

Collaborators

  • Governors State University

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Dec 13, 2024

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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