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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorScott Getsoian

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absent sensation of the areas to be cupped

Significant cognitive impairment

Pregnancy

Prescription anticoagulant medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dry Static Cupping

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cupping groupActive comparator 2 interventions
Group B: Placebo cupping groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Modified Ashworth Scale

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.

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

Secondary outcomes

1

Six-Minute Walk Test (6MWT)

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.

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

Timed Up and Go (TUG) Test

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.

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

Berg Balance Scale (BBS)

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): 1. sitting to standing 2. standing unsupported 3. sitting unsupported with feet on floor 4. standing to sitting 5. transfers 6. standing unsupported with eyes closed 7. standing unsupported with feet together 8. reaching forward with outstretched arm 9. pick up object from floor 10. turn to look behind over each shoulder 11. turning 360 degrees 12. dynamic weight shifting while standing unsupported 13. standing unsupported one foot in front 14. standing on one leg

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

Other outcomes

Sponsors and contacts

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Scott Getsoian

Lead sponsor

Ascension Health

Sponsor institution

Governors State University

Collaborator