Cold Therapy and Cross-Education of Muscle Strength

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status: Completed

Conditions: Muscle Weakness; Cerebrovascular Stroke

Treatments: Device: NMES; Other: Cold pack

Study type: Interventional

Funder types: Other

Identifiers

NCT04886843

IstanbulPMRTRH-ct

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Cold Therapy

Active Comparator group

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.

Treatment:

Device: NMES

Other: Cold pack

Control

Placebo Comparator group

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.

Treatment:

Device: NMES