Hemiparesis;Poststroke/CVA
Conditions
Keywords
Rehabilitation, Skeletal muscle, Eccentric strengthening
Brief summary
The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.
Detailed description
This study will be a single-blinded, controlled, randomized design, wherein participants will be randomly assigned to one of two groups: the Conventional Therapy Group (CTG) or the Eccentric Training Group (ETG). Both groups will undergo a comprehensive series of assessments at three key time points: Ji (initial assessment), Jint (intermediate assessment), and Jf (final assessment). The study will commence with a recruitment phase, followed by a screening phase. Subsequently, there will be a 4-week period allocated for experimental testing before the intervention, and an additional 4 weeks for experimental testing after the intervention. These assessments will encompass a wide range of evaluations, including clinical health assessments, biomechanical assessments, neuromuscular evaluations, and functional assessments
Interventions
PROCEDUREEccentric training
The eccentric program will last for 16 weeks, with a frequency of 2 sessions per week, totalling 32 sessions. At least 1 day of rest will be required between two training sessions. The participants will be placed in the similar position of the neuromuscular assessments (reference position). The Biodex System 4 dynamometer settings for the exercise sessions were also like the settings used for the assessments. The training program will be divided into two phases: a familiarization phase and a progression phase
PROCEDUREConventional therapy
3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation
Sponsors
Henri Mondor University Hospital
Clinique Du Parc de Belleville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subacute hemiparesis (\> 3 months) * BMI between 18.5 and 25 * Written consent to participate in the study.
Exclusion criteria
* Ankle impairment * Botulinum toxin injections in PF within the last 4 months before study inclusion * Medical contraindication for maximal effort * Neurodegenerative disorders * Cardiovascular disorders * History of epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gait speed (m/s) through the 10-meter walking test. | initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion | An analysis of the walking pattern will be conducted to quantify the evolution of spatio-temporal and barometric parameters of walking and their asymmetry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanical proprieties | initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion | muscle stiffness, as expressed by the shear modulus (µ, in Kpa), will be assessed during passive ankle joint mobilization from dorsiflexion to plantar flexion and during maximal voluntary isometric contraction of Plantar flexors |
| Structural parameters | initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion | Fascicle length and thickness (mm) will be assessed using the ultrasound scanner. |
| Neuromuscular parameters | initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion | Peak force (N/m), submaximal force (N/m) and rate of force development (N/m) will be evaluated using the BIODEX isokinetic device during maximal volontary contraction |
| Functional parameters | initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion | maximal range of motion (deg/s) , defined as the extent of stretch that the participant can comfortably endure during the stretching maneuver, will be measured using the BIODEX isokinetic device |
Countries
France
Contacts
Primary Contactbelghith kalthoum, Investigator
Backup ContactRayan Bouserhal, Investigator
Outcome results
None listed