Spasticity, Muscle Clinical Trial
Official title:
Immediate Effect of Capacitive Resistive Electric Transfer Therapy (CRet) Associated With Functional Massage on the Rectus Femoris and Gastrocnemius in Post-stroke Spasticity
NCT number | NCT04851756 |
Other study ID # | CRet2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 29, 2021 |
Est. completion date | September 5, 2022 |
Verified date | April 2023 |
Source | Universitat Internacional de Catalunya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 36 |
Est. completion date | September 5, 2022 |
Est. primary completion date | May 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Spain | Assessment Room at UIC Sant Cugat | Sant Cugat Del Vallès | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Universitat Internacional de Catalunya |
Spain,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ] | |
Primary | 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 | Active Range of Movement (AROM) of the anckle | Measuring change of the maximum range of active dorsiflexion with an inclinometer by the dorsiflexion lunge test. The participant will be standing and holding on a wall. The tester will ask the participant to bend her ankle to her maximum range without lifting her heel from the floor. | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ] | |
Secondary | AROM of the knee | Measuring change of the maximum range of active knee flexion on three point ( 0= no knee flexion, 1= knee does not reach = or < 90 degrees, 2= knee flexion >90 ) Fugl Meyer Assessment. Only the lower extremity item of the Fugl Meyer assessment will be used in this study. | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ] | |
Secondary | Global Improvement | Global Improvement on two 5 points Likert Scale questions:
(1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree. |
Baseline up 30 min after treatment |
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