Cold Therapy and Cross-Education of Muscle Strength

Not Applicable

Completed

• Conditions: Muscle Weakness; Cerebrovascular Stroke

• Registration Number: NCT04886843
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Study Timeline

• Study Start: 2020-01-23
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of ankle dorsiflexor isometric muscle strength	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

Secondary Outcome Measures

Name	Time	Method
Change of Lower Extremity Brunnstrom Score	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 of Modified Ashworth Scale Score	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 of Functional Ambulation Scale Score	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 of Timed Up and Go Test Score	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.

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital; 🇹🇷 Istanbul, Turkey