search
Back to results

Upper Limb Cross-education in Subacute Stroke

Primary Purpose

Hemiplegia, Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS
Conventional rehabilitation
EMS
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hemiplegia focused on measuring Cross-education, Interlimb transfer, Electro muscular stimulation, Muscle strength

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • thromboembolic stroke,
  • <6 months of stroke,
  • right hand dominancy,
  • left hemiplegia,
  • Brunnstrom stage ≥ 3 of recovery for upper extremity and hand

Exclusion Criteria:

  • myopathy, tendinopathy, peripheral neuropathy of the upper extremities,
  • auditory, cognitive or speech disorder that enables communication,
  • history of fracture or arthrodesis in the upper limb,
  • contracture or severe spasticity (Ashworth scale ≥ 2) in forearm muscles,
  • severe cardiovascular disorders (heart failure, coronary artery disease, drug resistant hypertension)

Sites / Locations

  • Bezmialem University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

TENS group

EMS group

Arm Description

30 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training program, patients will receive 30 minutes of conventional antalgic TENS (100 Hz) program as controls with electrostimulation device to the non-paretic wrist flexors.

0 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training, the patients will receive 20 minutes of electrical stimulation to their non-paretic forearm upon wrist flexors by an intermittent maximum strength program (6 seconds of contraction, 10 seconds of rest) along with 5 minutes of pre and post warm-up with the same device.

Outcomes

Primary Outcome Measures

The Fugl-Meyer motor function assessment for upper extremity
This scale is designed to assess reflex activity, volitional activities (within synergies, mixing synergies, with little or no synergy), wrist and hand joint functioning, and coordination of the upper extremity in patients with post-stroke hemiplegia. This scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. Maximum score in the upper limb is 66 and higher scores represent a better outcome
The functional independence measure
This scale is an assessment tool which evaluate the functional status of patients throughout the rehabilitation process. Degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence. Total score varies between 18 to 126 and higher scores represent a more independent patient
Brunnstrom stage of recovery for hand
This staging evaluates patient according to six sequential stages of recovery as stage 1: flaccidity, 2: basic limb synergy with minimal spasticity, 3: synergy with marked spasticity, 4: limited ability to move normally with reduced spasticity, 5: complex movement combinations, and 6: motor control is almost fully recovered. A patient can plateau at any stage but if able to reach stage 6 he or she makes full recovery
Maximum and mean strength of paretic wrist flexors
While the patient lays in supine on a bad, a physician stabilizes the forearm of the patient and measures the wrist flexion power with a manual muscle tester device while patient's forearm is in supination. This device can measure maximal power and mean power during 10 seconds of pressure. Circular cap of the device is used as application surface and the cap is placed on palm for wrist flexion for measurement. Then the patient is asked to perform a maximum wrist flexion for ten seconds. The device notices the patient for time with two sounds at starting or finishing the measurement. The maximum and mean wrist flexion force, wrist extension force is recorded in kilograms after the measurement.
Maximum and mean strength of paretic wrist extensors
While the patient lays in supine on a bad, a physician stabilizes the forearm of the patient and measures the wrist extension power with a manual muscle tester (Lafayette instrument company, IN, USA) device while patient's forearm is in pronation. This device can measure maximal power and mean power during 10 seconds of pressure. Circular cap of the device is used as application surface and the cap is placed on the middle of hand dorsum for wrist extension measurement. Then the patient is asked to perform a maximum wrist extension for ten seconds. The device notices the patient for time with two sounds at starting or finishing the measurement. The maximum and mean extension flexion force is recorded in kilograms after the measurement

Secondary Outcome Measures

Full Information

First Posted
October 1, 2019
Last Updated
April 9, 2020
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT04113369
Brief Title
Upper Limb Cross-education in Subacute Stroke
Official Title
How Does Cross-education Affect Muscles of Paretic Upper Extremity in Subacute Stroke Survivors?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates how cross-education (unilateral training) affects muscle strength of the paretic limb in acute stroke patients. Half of the hemiplegic patients will receive conventional treatment and transcutaneous electrical nerve stimulation (TENS) to non-paretic side, while other half will receive conventional treatment and electro muscular stimulation (EMS) to non-paretic side.
Detailed Description
Cross-education, which means the performance improvement in the untrained homologous muscle after unilateral exercise training, is studied in various orthopedical and neurological conditions affecting the body unilaterally. For those with asymmetrical weakness and immobility after stroke, training the non-paretic side can be utilized to increase the strength of the paretic side and improve functional symmetry. In this study, investigators aim was to examine whether training non-paretic upper extremity wrist flexor muscles by EMS in adjunct to conventional training program, has additional benefits upon the muscle powers of the homologous agonist and antagonist muscles. Investigators will use low frequency antalgic TENS stimulation at barely sensible level, which is considered not to cause muscle strengthening, as a control intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke
Keywords
Cross-education, Interlimb transfer, Electro muscular stimulation, Muscle strength

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS group
Arm Type
Sham Comparator
Arm Description
30 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training program, patients will receive 30 minutes of conventional antalgic TENS (100 Hz) program as controls with electrostimulation device to the non-paretic wrist flexors.
Arm Title
EMS group
Arm Type
Active Comparator
Arm Description
0 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training, the patients will receive 20 minutes of electrical stimulation to their non-paretic forearm upon wrist flexors by an intermittent maximum strength program (6 seconds of contraction, 10 seconds of rest) along with 5 minutes of pre and post warm-up with the same device.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
30 minutes of conventional antalgic TENS to non-paretic forearm
Intervention Type
Procedure
Intervention Name(s)
Conventional rehabilitation
Intervention Description
40 minutes of lower limb training and 20 minutes of upper extremity training for stroke
Intervention Type
Device
Intervention Name(s)
EMS
Intervention Description
20 minutes of EMS to non-paretic forearm with 5 minutes of pre and post warm-up
Primary Outcome Measure Information:
Title
The Fugl-Meyer motor function assessment for upper extremity
Description
This scale is designed to assess reflex activity, volitional activities (within synergies, mixing synergies, with little or no synergy), wrist and hand joint functioning, and coordination of the upper extremity in patients with post-stroke hemiplegia. This scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. Maximum score in the upper limb is 66 and higher scores represent a better outcome
Time Frame
6 weeks
Title
The functional independence measure
Description
This scale is an assessment tool which evaluate the functional status of patients throughout the rehabilitation process. Degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence. Total score varies between 18 to 126 and higher scores represent a more independent patient
Time Frame
6 weeks
Title
Brunnstrom stage of recovery for hand
Description
This staging evaluates patient according to six sequential stages of recovery as stage 1: flaccidity, 2: basic limb synergy with minimal spasticity, 3: synergy with marked spasticity, 4: limited ability to move normally with reduced spasticity, 5: complex movement combinations, and 6: motor control is almost fully recovered. A patient can plateau at any stage but if able to reach stage 6 he or she makes full recovery
Time Frame
6 weeks
Title
Maximum and mean strength of paretic wrist flexors
Description
While the patient lays in supine on a bad, a physician stabilizes the forearm of the patient and measures the wrist flexion power with a manual muscle tester device while patient's forearm is in supination. This device can measure maximal power and mean power during 10 seconds of pressure. Circular cap of the device is used as application surface and the cap is placed on palm for wrist flexion for measurement. Then the patient is asked to perform a maximum wrist flexion for ten seconds. The device notices the patient for time with two sounds at starting or finishing the measurement. The maximum and mean wrist flexion force, wrist extension force is recorded in kilograms after the measurement.
Time Frame
6 weeks
Title
Maximum and mean strength of paretic wrist extensors
Description
While the patient lays in supine on a bad, a physician stabilizes the forearm of the patient and measures the wrist extension power with a manual muscle tester (Lafayette instrument company, IN, USA) device while patient's forearm is in pronation. This device can measure maximal power and mean power during 10 seconds of pressure. Circular cap of the device is used as application surface and the cap is placed on the middle of hand dorsum for wrist extension measurement. Then the patient is asked to perform a maximum wrist extension for ten seconds. The device notices the patient for time with two sounds at starting or finishing the measurement. The maximum and mean extension flexion force is recorded in kilograms after the measurement
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: thromboembolic stroke, <6 months of stroke, right hand dominancy, left hemiplegia, Brunnstrom stage ≥ 3 of recovery for upper extremity and hand Exclusion Criteria: myopathy, tendinopathy, peripheral neuropathy of the upper extremities, auditory, cognitive or speech disorder that enables communication, history of fracture or arthrodesis in the upper limb, contracture or severe spasticity (Ashworth scale ≥ 2) in forearm muscles, severe cardiovascular disorders (heart failure, coronary artery disease, drug resistant hypertension)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozan Volkan Yurdakul, MD
Organizational Affiliation
Bezmialem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17043329
Citation
Carroll TJ, Herbert RD, Munn J, Lee M, Gandevia SC. Contralateral effects of unilateral strength training: evidence and possible mechanisms. J Appl Physiol (1985). 2006 Nov;101(5):1514-22. doi: 10.1152/japplphysiol.00531.2006.
Results Reference
background
PubMed Identifier
23196803
Citation
Dragert K, Zehr EP. High-intensity unilateral dorsiflexor resistance training results in bilateral neuromuscular plasticity after stroke. Exp Brain Res. 2013 Mar;225(1):93-104. doi: 10.1007/s00221-012-3351-x. Epub 2012 Nov 30.
Results Reference
background
PubMed Identifier
26074871
Citation
Urbin MA, Harris-Love ML, Carter AR, Lang CE. High-Intensity, Unilateral Resistance Training of a Non-Paretic Muscle Group Increases Active Range of Motion in a Severely Paretic Upper Extremity Muscle Group after Stroke. Front Neurol. 2015 May 27;6:119. doi: 10.3389/fneur.2015.00119. eCollection 2015.
Results Reference
background
PubMed Identifier
32506358
Citation
Yurdakul OV, Kilicoglu MS, Rezvani A, Kucukakkas O, Eren F, Aydin T. How does cross-education affects muscles of paretic upper extremity in subacute stroke survivors? Neurol Sci. 2020 Dec;41(12):3667-3675. doi: 10.1007/s10072-020-04506-2. Epub 2020 Jun 6.
Results Reference
derived

Learn more about this trial

Upper Limb Cross-education in Subacute Stroke

We'll reach out to this number within 24 hrs