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

NCT04312581 | Completed

• 1 other identifier: 101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spasticity; Shock Wave

Keywords

shock wave

Outcome Measures

Primary Outcomes (4)

• Modified Ashworth Scale

  is a valid scoring system for spasticity

  Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

• Fugl-Meyer Assessment

  reliable assessment tool for sensorimotor function of the upper extremity of stroke patients

  Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

• Motricity Index

  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

  Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

• Hmax / Mmax amplitude ratio

  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

  Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

Study Arms (2)

First group (shock wave)

EXPERIMENTAL

Extracorporeal shock wave therapy

Device: Extracorporeal shock wave therapy

Second group (conventional rehabilitation)

ACTIVE COMPARATOR

conventional rehabilitation

Other: Conventional rehabilitation

Interventions

Extracorporeal shock wave therapy DEVICE

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.

First group (shock wave)

Conventional rehabilitation OTHER

physical \& occupational therapy

Second group (conventional rehabilitation)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university hospital

Tanta, Gharbia Governorate, 31527, Egypt

Location

Related Publications (1)

• Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.

  PMID: 27149465 RESULT

Related Links

• Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 18, 2020
• Study Start: March 21, 2020
• Primary Completion: July 29, 2020
• Study Completion: July 29, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

EG (1)