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Cold Therapy and Cross-Education of Muscle Strength

Primary Purpose

Cerebrovascular Stroke, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold pack
NMES
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring Cold therapy, Cross-education, Neuromuscular electrical stimulation, Hemiplegia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cases with stroke duration ≥1 month
  • Brunnstrom stage ≥4 for lower limb
  • Unilateral stroke
  • Ability to walk at least 10 m (FAC ≥3)
  • Cooperating with the examination and tests

Exclusion Criteria:

  • Cold allergy
  • Active inflammatory, rheumatological, or infectious disease
  • Presence of lower extremity fracture
  • Severe spasticity (MAS> 3) in ankle dorsiflexors
  • Peripheral nerve lesions such as polyneuropathy, radiculopathy
  • Parent rhythm/conduction block problem in the heart
  • Uncontrollable hypertension (Maxima >140 mmHg, Minima >90 mmHg)
  • Have a contracture on the ankle joint
  • The presence of skin lesions in the application area
  • Finding or suspected active deep vein thrombosis

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cold Therapy

Control

Arm Description

The patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week. In addition to this application, a cold pack was applied on the affected side dorsiflexor muscle skin. The cold pack was applied on a moist towel for five minutes. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES.

The patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week.

Outcomes

Primary Outcome Measures

Change of ankle dorsiflexor isometric muscle strength
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force

Secondary Outcome Measures

Change of Lower Extremity Brunnstrom Score
This test describes the sequences of motor recovery after stroke based on the muscle tone, synergy patterns and isolated movements. Brunnstrom classified stages of recovery into six stages. Stage 1 and 6. Stage 1:Flaccidity; Stage 6: Spasticity disappears and individual joint movements become possible
Change of Modified Ashworth Scale Score
The modified Ashworth scale is the tool used to measure the increase of muscle tone. The modified Ashworth scale is score is graded between 0 and 4. 0: No increase in muscle tone, 4: Affected part(s) rigid in flexion or extension
Change of Functional Ambulation Scale Score
The Functional Ambulation Classification (FAC) is a functional walking test that evaluates ambulation ability. Patients are categorized between 0 (non-functional ambulation) and 6 (independent).
Change of Timed Up and Go Test Score
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

Full Information

First Posted
May 9, 2021
Last Updated
May 11, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04886843
Brief Title
Cold Therapy and Cross-Education of Muscle Strength
Official Title
The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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
The aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients.
Detailed Description
In this prospective randomized controlled single-blind study, a total of 25 patients, 16 men, and 9 women were included according to inclusion and exclusion criteria. Patients were randomly assigned to the experimental group (n=12) or the control group (n=13). NMES has applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups. In addition to the experimental group, the cold application was applied on the affected side dorsiflexor muscle skin. The cold application was done on a moist towel for five minutes using a cold pack. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. A conventional rehabilitation program was applied to all patients by a physiotherapist. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke, Muscle Weakness
Keywords
Cold therapy, Cross-education, Neuromuscular electrical stimulation, Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold Therapy
Arm Type
Active Comparator
Arm Description
The patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week. In addition to this application, a cold pack was applied on the affected side dorsiflexor muscle skin. The cold pack was applied on a moist towel for five minutes. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week.
Intervention Type
Other
Intervention Name(s)
Cold pack
Intervention Description
Five minutes cold pack was applied on the affected side dorsiflexor muscle skin, a five-minute break was given and a further 5-minute cold application was repeated
Intervention Type
Device
Intervention Name(s)
NMES
Intervention Description
NMES was applied to the nonaffected side ankle dorsiflexors
Primary Outcome Measure Information:
Title
Change of ankle dorsiflexor isometric muscle strength
Description
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
Time Frame
Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days
Secondary Outcome Measure Information:
Title
Change of Lower Extremity Brunnstrom Score
Description
This test describes the sequences of motor recovery after stroke based on the muscle tone, synergy patterns and isolated movements. Brunnstrom classified stages of recovery into six stages. Stage 1 and 6. Stage 1:Flaccidity; Stage 6: Spasticity disappears and individual joint movements become possible
Time Frame
Change from Baseline Lower Extremity Brunnstrom Score at 6 days
Title
Change of Modified Ashworth Scale Score
Description
The modified Ashworth scale is the tool used to measure the increase of muscle tone. The modified Ashworth scale is score is graded between 0 and 4. 0: No increase in muscle tone, 4: Affected part(s) rigid in flexion or extension
Time Frame
Change from Baseline Modified Ashworth Scale Score at 6 days
Title
Change of Functional Ambulation Scale Score
Description
The Functional Ambulation Classification (FAC) is a functional walking test that evaluates ambulation ability. Patients are categorized between 0 (non-functional ambulation) and 6 (independent).
Time Frame
Change from Baseline Functional Ambulation Scale Score at 6 days
Title
Change of Timed Up and Go Test Score
Description
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Time Frame
Change from Baseline Change of Timed Up and Go Test Score at 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cases with stroke duration ≥1 month Brunnstrom stage ≥4 for lower limb Unilateral stroke Ability to walk at least 10 m (FAC ≥3) Cooperating with the examination and tests Exclusion Criteria: Cold allergy Active inflammatory, rheumatological, or infectious disease Presence of lower extremity fracture Severe spasticity (MAS> 3) in ankle dorsiflexors Peripheral nerve lesions such as polyneuropathy, radiculopathy Parent rhythm/conduction block problem in the heart Uncontrollable hypertension (Maxima >140 mmHg, Minima >90 mmHg) Have a contracture on the ankle joint The presence of skin lesions in the application area Finding or suspected active deep vein thrombosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilhan Karacan, Assoc Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
City
Istanbul
ZIP/Postal Code
34173
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21496110
Citation
Sariyildiz M, Karacan I, Rezvani A, Ergin O, Cidem M. Cross-education of muscle strength: cross-training effects are not confined to untrained contralateral homologous muscle. Scand J Med Sci Sports. 2011 Dec;21(6):e359-64. doi: 10.1111/j.1600-0838.2011.01311.x. Epub 2011 Apr 18.
Results Reference
background
PubMed Identifier
17190532
Citation
Lee M, Carroll TJ. Cross education: possible mechanisms for the contralateral effects of unilateral resistance training. Sports Med. 2007;37(1):1-14. doi: 10.2165/00007256-200737010-00001.
Results Reference
background
PubMed Identifier
23898251
Citation
Howatson G, Zult T, Farthing JP, Zijdewind I, Hortobagyi T. Mirror training to augment cross-education during resistance training: a hypothesis. Front Hum Neurosci. 2013 Jul 24;7:396. doi: 10.3389/fnhum.2013.00396. eCollection 2013.
Results Reference
background
PubMed Identifier
26907193
Citation
Ehrensberger M, Simpson D, Broderick P, Monaghan K. Cross-education of strength has a positive impact on post-stroke rehabilitation: a systematic literature review. Top Stroke Rehabil. 2016 Apr;23(2):126-35. doi: 10.1080/10749357.2015.1112062. Epub 2016 Feb 24.
Results Reference
background
PubMed Identifier
28325123
Citation
Tokunaga T, Sugawara H, Tadano C, Muro M. Effect of stimulation of cold receptors with menthol on EMG activity of quadriceps muscle during low load contraction. Somatosens Mot Res. 2017 Jun;34(2):85-91. doi: 10.1080/08990220.2017.1299004. Epub 2017 Mar 21.
Results Reference
background
PubMed Identifier
25218791
Citation
Shimose R, Ushigome N, Tadano C, Sugawara H, Yona M, Matsunaga A, Muro M. Increase in rate of force development with skin cooling during isometric knee extension. J Electromyogr Kinesiol. 2014 Dec;24(6):895-901. doi: 10.1016/j.jelekin.2014.08.002. Epub 2014 Aug 24.
Results Reference
background

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Cold Therapy and Cross-Education of Muscle Strength

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