Cold Therapy and Cross-Education of Muscle Strength

May 11, 2021 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34173
        • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cold Therapy
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.
Other: Cold pack
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
Device: NMES
NMES was applied to the nonaffected side ankle dorsiflexors
Placebo Comparator: Control
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.
Device: NMES
NMES was applied to the nonaffected side ankle dorsiflexors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of ankle dorsiflexor isometric muscle strength
Time Frame: Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Lower Extremity Brunnstrom Score
Time Frame: Change from Baseline Lower Extremity Brunnstrom Score at 6 days
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 from Baseline Lower Extremity Brunnstrom Score at 6 days
Change of Modified Ashworth Scale Score
Time Frame: Change from Baseline Modified Ashworth Scale Score at 6 days
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 from Baseline Modified Ashworth Scale Score at 6 days
Change of Functional Ambulation Scale Score
Time Frame: Change from Baseline Functional Ambulation Scale Score at 6 days
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 from Baseline Functional Ambulation Scale Score at 6 days
Change of Timed Up and Go Test Score
Time Frame: Change from Baseline Change of Timed Up and Go Test Score at 6 days
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.
Change from Baseline Change of Timed Up and Go Test Score at 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Ilhan Karacan, Assoc Prof, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulPMRTRH-ct

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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