Cold Therapy and Cross-Education of Muscle Strength

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2020-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mirror Therapy and Cross-Education of Muscle Strength

NCT04887376

Cerebrovascular Stroke Muscle Weakness

COMPLETED NA

Upper Limb Cross-education in Subacute Stroke

NCT04113369

Hemiplegia Stroke

COMPLETED NA

Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals

NCT03811106

Hemiplegia

UNKNOWN NA

Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation

NCT04913506

Hemiplegia Upper Extremity Dysfunction

UNKNOWN NA

Kinesio Tape vs Neuromuscular Stimulation For Conserative of Treatment Hemiplegic Shoulder

NCT02937311

Hemiplegia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebrovascular Stroke Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Cold pack

Intervention Type OTHER

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

NMES

Intervention Type DEVICE

NMES was applied to the nonaffected side ankle dorsiflexors

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.

Group Type PLACEBO_COMPARATOR

NMES

Intervention Type DEVICE

NMES was applied to the nonaffected side ankle dorsiflexors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

NMES

NMES was applied to the nonaffected side ankle dorsiflexors

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No