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The effectiveness of radial Extracorporeal Shock Wave Therapy versus Transcutaneous Electrical Nerve Stimulation in the management of upper limb spasticity in chronic post-stroke hemiplegia: A randomized controlled trial

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SLCTR Registration Number

SLCTR/2019/040


Date of Registration

19 Dec 2019

The date of last modification

Dec 19, 2019


View original TRDS



Application Summary


Scientific Title of Trial

The effectiveness of radial Extracorporeal Shock Wave Therapy versus Transcutaneous Electrical Nerve Stimulation in the management of upper limb spasticity in chronic post-stroke hemiplegia: A randomized controlled trial


Public Title of Trial

The effectiveness of radial Extracorporeal Shock Wave Therapy versus Transcutaneous Electrical Nerve Stimulation in the management of upper limb spasticity in chronic post-stroke hemiplegia: A randomized controlled trial


Disease or Health Condition(s) Studied

stroke


Scientific Acronym

rESWT vs TENS


Public Acronym

None


Brief title

rESWT vs TENS for chronic post-stroke upper limb spasticity


Universal Trial Number

U1111-1243-1762


Any other number(s) assigned to the trial and issuing authority

2019/ EC/ 35


Trial Details


What is the research question being addressed?

Is radial extracorporeal shock wave therapy (rESWT) more effective than transcutaneous electrical nerve stimulation (TENS) in treating the upper limb spasticity of patients with chronic post-stroke hemiplegia?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used : Participants


Control

Active


Assignment

Single


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

The study will be conducted at teaching hospital, Peradeniya and at the Department of Physiotherapy, Faculty of Allied Health Sciences, University of Peradeniya..

The control group will receive transcutaneous electrical nerve stimulation (TENS), frequency of 100 Hz over Teres major, Brachialis, Flexor carpi ulnaris and Flexor digitorum profundus muscles, fifteen minutes for each muscle followed by task oriented exercises for upper limb for 30 minutes. The experimental group will receive radial extracorporeal shock wave therapy (rESWT), 1500 shots per muscle, frequency of 5Hz, energy of 0.030 mJ/mm, over Teres major, Brachialis, Flexor carpi ulnaris and Flexor digitorum profundus muscles followed by task oriented exercises for upper limb for 30 minutes. All the patients will receive transcutaneous electrical nerve stimulation or radial extracorporeal shock wave therapy once a week for four weeks continuously according to the group to which he or she was assigned. All the patients will receive the task oriented exercises three times per week for four weeks. All the subjects will be assessed for their voluntary movement grading for the upper limb, spasticity grading for upper limb and their hand function grading immediately after the TENS or rESWT treatment has been given, at the end of the four weeks of treatment and after eight, twelve, sixteen and twenty weeks. After four weeks of the treatment session patients will be asked to follow the task oriented exercises for upper limb at home.


Inclusion criteria

  1. Male and female patients aged between 40 to 70 years diagnosed with stroke resulting in hemiplegia more than six months ago 2.Stable spasticity (no variability within two months before recruitment) in upper limb
  2. Patients with more than grade three of Modified Ashwath Scale
    1. Patients with Voluntary Control Grading from two to four for affected UL
  3. Able to maintain standing position for five minutes without manual assistance
  4. Able and willing to participate in four weeks study and to sign consent form

Exclusion criteria

1.Patients with reflex sympathetic dystrophy/ severe shoulder subluxation/ shoulder dislocation/ contracture in the affected UL/ fixed deformity of hand/ shoulder hand syndrome 2.Any neurological disorder or pain that might limits arm movement 3. Patients who have received botox injection or acupuncture within past 6 months to the affected UL 4. Complete sensory loss of upper limb 5. Presence of high risk cardiovascular disorders such as myocardial infarction, heart failure 6. Severe hypertension defined as SBP? 180 and or DBP ? 110 7. Presence of convulsions 8. Patients with visual impairment 9. Patients with behavioral problems 10. Already enrolled in some form of physical therapy



Primary outcome(s)

1.

• Spasticity grading of affected upper limb using Modified Ashwath scale • Voluntary control of affected upper limb according to a grading system

[

All the subjects will be assessed for spasticity of upper limb and voluntary control of upper limb immediately after the TENS or rESWT treatment has been given, and at the end of the four weeks treatment session eight, twelve, sixteen and twenty weeks after the first treatment

]

Secondary outcome(s)

1.

• Fugl - Meyer motor assessment of physical performance of upper limb • Action research arm test

[

All the subjects will be assessed for hand function grading immediately after the TENS or rESWT treatment has been given, at the end of the four weeks treatment session and after eight, twelve, sixteen and twenty weeks after the first treatment

]

Target number/sample size

108 in total


Countries of recruitment

Sri Lanka


Anticipated start date

2019-12-20


Anticipated end date

2021-12-20


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-10-17


Approval number

2019/EC/35


Details of Ethics Review Committee

Name: Ethics review committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Ethics review committee, Faculty of Medicine, University of Peradeniya, Sri Lanka
Telephone:0812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

M.K.I.Dilhari Senarath
Lecturer (Probationary)
Department of Physiotherapy Faculty of Allied Health Sciences University of Peradeniya
0813999623
072379970/ 0713720006

dilsenarath7@gmail.com/ dilharisenarath@ahs.pdn.ac.lk

Contact Person for Public Queries

Dr. L.P.M.M.K. Pathirage,
Senior Lecturer (Consultant Physician),
Department of Medicine, Faculty of Medicine, University of Peradeniya. +94812396470
+94812396470
0714877008

manojipathi@yahoo.com


Primary study sponsor/organization

University of Peradeniya





Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results