Cold Therapy and Cross-Education of Muscle Strength

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04886843
Collaborator
(none)
25
1
2
9.2
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cold pack
  • Device: NMES
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia
Actual Study Start Date :
Jan 23, 2020
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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).

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine Rehabilitation Training & Research Hospital Istanbul Turkey 34173

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04886843
Other Study ID Numbers:
  • IstanbulPMRTRH-ct
First Posted:
May 14, 2021
Last Update Posted:
May 14, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2021