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Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients

Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04312581
Enrollment
40
Registered
2020-03-18
Start date
2020-03-21
Completion date
2020-07-29
Last updated
2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock Wave, Spasticity, Stroke

Keywords

shock wave

Brief summary

40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional rehabilitative program. Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.

Interventions

DEVICEExtracorporeal shock wave therapy

3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency.

OTHERConventional rehabilitation

physical & occupational therapy

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with chronic stroke with disease duration more than one year will be included in the study with stable modified Ashworth scale for upper limb spasticity ranged from 1+ to 4.

Exclusion criteria

* Patients more than 65 years,Patients with double stroke and patients with fixed contractures of wrist & hand ,Patients received anti-spastic measures (botulinum toxins, nerve block) within 6 months,Also patients with contraindication to extra-corporeal shock wave therapy i.e. malignancy at treatment area, coagulopathies, active infection (viral or TB), o bleeding wounds, and patients with pacemakers will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Modified Ashworth ScaleChange from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)is a valid scoring system for spasticity
Fugl-Meyer AssessmentChange from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)reliable assessment tool for sensorimotor function of the upper extremity of stroke patients
Motricity IndexChange from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)used to assess the motor impairment in a patient with stroke, only one item (pinch grip) was tested using a 2.5 cm cube between the thumb and forefinger * 19 points are given if able to grip cube but not hold it against gravity * 22 points are given if able to hold cube against gravity but not against a weak pull * 26 points are given if able to hold the cube against a weak pull but strength is weaker than normal
Hmax / Mmax amplitude ratioChange from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)H reflex is an electrically triggered spinal reflex with a fairly constant latency and amplitude on repeated testing.Hmax / Mmax amplitude ratio was obtained from patient's spastic upper limb, flexor carpi radials muscle

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026