Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity

NCT04851756 | Completed

• 1 other identifier: CRet2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the immediate effects of CRet associated to Functional Massage (F.M) in terms of gait and functionality after stroke

Conditions

Stroke Sequelae; Spasticity, Muscle; Massage; Electrotherapy

Keywords

Stroke; Spasticity; Functional Massage; CRet; Functionality; Gait

Outcome Measures

Primary Outcomes (2)

• Gait Performance

  To evaluate change in gait speed after one session with CRet associated to F.M by the 4-metre-walk-test (4MWT). The assessor will indicate the participant to walk 4m at her fastest velocity. The timing will ve recorded.

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]

• Functional Lower Extremity Force

  To evaluate change in functional lower extremity force after one session with CRet associated to F.M by the 5 times sit-to-stand test. Participants will be in the seating position on the treatment bed, and will stand and sit for five times. Time will start when the tester says 'go'.Time will stop when the participant's body touches the chair following the fifth repetition.

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]

Secondary Outcomes (3)

• Active Range of Movement (AROM) of the anckle

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]

• AROM of the knee

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]

• Global Improvement

  Baseline up 30 min after treatment

Study Arms (2)

CRet Group

EXPERIMENTAL

30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis

Device: CRet

CRet Sham Group

SHAM COMPARATOR

30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis with turned on CRet device at power 0

Device: Sham CRet

Interventions

CRet DEVICE

In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (80-100W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (100-120 W) on the hamstrings. Then a 5 min Functional Massage (F.M) with passive anckle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min F.M with CRet on capacitive mode (180-250VA) on the mentioned area. In supine position, a 5 min F.M with passive knee flexion and CRet on resistive mode (110-140W) will be performed on the rectus femoris, followed by a 4 min F.M with passive knee flexion and CRet on capacitive mode (180-250VA) on the mentioned area. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes.

CRet Group

Sham CRet DEVICE

In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (0 W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (0 W) on the hamstrings. Then a 5 min Functional Massage (F.M) with passive anckle dorsiflexion and CRet on resistive mode (0 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (0 VA) on the mentioned area. In supine position, a 5 min F.M with passive knee flexion and CRet on resistive mode (0W) will be performed on the rectus femoris, followed by a 4 min F.M with passive knee flexion and CRet on capacitive mode (0VA) on the mentioned area. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes.

CRet Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke
• Scoring 1+ on the Modified Ashworth Scale (MAS) for hip flexion and/or knee flexion or/and ancke dorsiflexion on the most affected limb
• Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)
• Signing the informed consent form

You may not qualify if:

• Having suffered a traumatism on the lower limbs three months, or less, before the intervention
• Other neurological diseases
• Presence of osteosynthetic material
• Pacemaker wearing
• Treatment with botulinum toxin or another antispastic medication, six months , or less, before the intervention
• Carry baclofen pump
• Functional inability to adopt the prone or supine position on the treatment table
• Functional inability to sit, stand and walk
• Poor language and communication skills that make difficult to understand the informed consent form
• Contraindications to Functional Massage (infectious diseases, inflammatory vascular conditions, acute inflammation, haemorrhagia, fever)

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Assessment Room at UIC Sant Cugat

Sant Cugat del Vallès, Catalonia, 08195, Spain

Location

Related Publications (22)

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MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rosa Cabanas-Valdés, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 20, 2021
• Study Start: April 29, 2021
• Primary Completion: May 27, 2022
• Study Completion: September 5, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)