Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)ISOWALKNCT05887440
Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust
A study testing isokinetic strength training of knee extensor and flexor muscles in people with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) and Gait Disorder, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to assess the impact of an isokinetic strength training of knee flexor and extensor muscles on walking performance in hemiparetic patients with knee extension thrust. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder
- What is being tested?
- isokinetic strength training of knee extensor and flexor muscles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiparetic patient (hemorragic or ischemic stroke)
- Subacute stage (< 6 Months) ou chronic stage of stroke (> 6 months) (6 patients in each group)
- Age between 18 and 75 years
- Able to walk 10 meters independently without any assistive devices
- Knee extension thrust during stance phase of gait cycle (rapid posterior movement of the knee toward extension)
- Scheduled rehabilitation program with isokinetic strength training
- affiliation to a social security
- Patients who received and signed informed consent
Who cannot join
- Major comprehension deficit that not allow to give informed consent and participate to isokinetic strength training (assessed with comprehension subscore of Langague screening Test)
- non stable (unstable cardiovascular condition)
- musculoskeletal disorders with knee pain that not allowed isokinetic strength training
- Botulinum toxin injection less than 3 months or repeated injection in lower limb,
- Proprioception trouble assessed with proprioception section of the Fugl-Meyer Assessment [FMA-P] 0/2
- spasticity of triceps surae ≥2 (Modified Ashworth scale)
Show all 9Show fewer
- ankle dorsiflexion angle less than 90°
- pregnant women or breastfeeding
- persons with safety measure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Rennes
Rennes, 35033
Sophie HAMEAU, sophie.hameau@chu-rennes.fr
About this study
Official title: Effects of Isokinetic Strength Training of Knee Flexor and Extensor Muscles on Walking in Hemiparetic Patients With Knee Extension Thrust
The purpose of this study is to assess the impact of an isokinetic strength training of knee flexor and extensor muscles on walking performance in hemiparetic patients with knee extension thrust.
Read the detailed description
The study will be interventional single case experimental design (SCED) with multiple baseline design. SCED are experimental designs aiming at testing the effect of an intervention using a small number of patients using repeated measurements, sequential and randomized introduction of an intervention and method-specific data analysis, including visual analysis and specific statistics.
During baseline, patients will have a rehabilitation program in day hospital (4 days per week) with physiotherapy and physical activity and if necessary occupational and speech therapy. Isokinetic strength training will be added to this conventionnal rehabilitation program and will begin after 3, 4 or 5 weeks of baseline according to randomization
12 patients will be included in this study (6 patients in subacute stage and 6 in chronic stage ).
- Being tested
- isokinetic strength training of knee extensor and flexor muscles
- Keywords
- Stroke, Extensor thrust, resistance training, Isokinetic, walking speed, rehabilitation
- Medical subject headings
- Paresis, Hemiplegia, Mobility Limitation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic strength training of knee extensor and flexor musclesBehavioural
Patients underwent an isokinetic strength training program with 3 sessions per week during five weeks.
Program consists of excentric contraction of knee flexor and extensor muscles (4 x 7 Contractions at 30°/s) and concentric contractions at maximal speed where patients can perform 40% of his maximal isometric torque for knee flexor and extensor muscles (2x10 for knee flexors and 2x10 for knee extensors)
| Study group | Role | What they receive |
|---|---|---|
| 3 assessments | Experimental | The randomisation provides for 3 assessments of baseline Receives: Behavioral: isokinetic strength training of knee extensor and flexor muscles |
| 4 assessments | Experimental | The randomisation provides for 4 assessments of baseline Receives: Behavioral: isokinetic strength training of knee extensor and flexor muscles |
| 5 assessments | Experimental | The randomisation provides for 5 assessments of baseline Receives: Behavioral: isokinetic strength training of knee extensor and flexor muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
spontaneous walking speed
Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis
Measured: 25 weeks
Secondary outcomes (10)
Extensor thrust analysis
Extensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis
Measured: 25 weeks
Walking speed
assessment of walking speed in two conditions (maximal speed and dual task)
Measured: 25 weeks
Stairs test
time to ascend and descend stairs (maximal speed)
Measured: 25 weeks
Inclined plan
time to walk in an inclined plan (maximal speed)
Measured: 25 weeks
6-minute walk test
Assessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT)
Measured: 25 weeks
Sit to stand test
1 minute sit to stand test (number of repetitions)
Measured: 25 weeks
Extensor thrust during locomotor tasks
Extensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand )
Measured: 25 weeks
Fatigue
Fatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue)
Measured: 25 weeks
Likert Scale
self perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale
Measured: 25 weeks
Strength
strength of knee flexor and extensor muscles assessed with isokinetic dynamometer
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start21 Aug 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Single Case Experimental Design (SCED)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie HAMEAU, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887440
- Sponsor's protocol ID
- 35RC20_9899_ISOWALK
- Acronym
- ISOWALK
- Status last verified
- Sep 2023
- First submitted
- 14 Apr 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isokinetic Strength Training of Knee Flexor and Extensor Muscles on Walking in Hemiparetic Patients With Knee Extension Thrust
- ClinicalTrials.gov ID
- NCT05887440
- Acronym / sponsor ID
- ISOWALK / 35RC20_9899_ISOWALK
- Keywords
- Stroke, Extensor thrust, resistance training, Isokinetic, walking speed, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the impact of an isokinetic strength training of knee flexor and extensor muscles on walking performance in hemiparetic patients with knee extension thrust.
Detailed description
The study will be interventional single case experimental design (SCED) with multiple baseline design. SCED are experimental designs aiming at testing the effect of an intervention using a small number of patients using repeated measurements, sequential and randomized introduction of an intervention and method-specific data analysis, including visual analysis and specific statistics.
During baseline, patients will have a rehabilitation program in day hospital (4 days per week) with physiotherapy and physical activity and if necessary occupational and speech therapy. Isokinetic strength training will be added to this conventionnal rehabilitation program and will begin after 3, 4 or 5 weeks of baseline according to randomization
12 patients will be included in this study (6 patients in subacute stage and 6 in chronic stage ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single Case Experimental Design (SCED)
| Arm | Type | Receives |
|---|---|---|
| 3 assessments | Experimental | Behavioral: isokinetic strength training of knee extensor and flexor musclesThe randomisation provides for 3 assessments of baseline |
| 4 assessments | Experimental | Behavioral: isokinetic strength training of knee extensor and flexor musclesThe randomisation provides for 4 assessments of baseline |
| 5 assessments | Experimental | Behavioral: isokinetic strength training of knee extensor and flexor musclesThe randomisation provides for 5 assessments of baseline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hemiparetic patient (hemorragic or ischemic stroke)
- Subacute stage (< 6 Months) ou chronic stage of stroke (> 6 months) (6 patients in each group)
- Age between 18 and 75 years
- Able to walk 10 meters independently without any assistive devices
- Knee extension thrust during stance phase of gait cycle (rapid posterior movement of the knee toward extension)
Key exclusion criteria (9 listed)
- Major comprehension deficit that not allow to give informed consent and participate to isokinetic strength training (assessed with comprehension subscore of Langague screening Test)
- non stable (unstable cardiovascular condition)
- musculoskeletal disorders with knee pain that not allowed isokinetic strength training
- Botulinum toxin injection less than 3 months or repeated injection in lower limb,
- Proprioception trouble assessed with proprioception section of the Fugl-Meyer Assessment [FMA-P] 0/2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isokinetic strength training of knee extensor and flexor musclesPatients underwent an isokinetic strength training program with 3 sessions per week during five weeks. Program consists of excentric contraction of knee flexor and extensor muscles (4 x 7 Contractions at 30°/s) and concentric contractions at maximal speed where patients can perform 40% of his maximal isometric torque for knee flexor and extensor muscles (2x10 for knee flexors and 2x10 for knee extensors) | Behavioural | 3 assessments, 4 assessments, 5 assessments |
Primary outcome
spontaneous walking speed
Time frame: 25 weeks
Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis
10 secondary outcomes
Extensor thrust analysis
Time frame: 25 weeks
Walking speed
Time frame: 25 weeks
Stairs test
Time frame: 25 weeks
Inclined plan
Time frame: 25 weeks
6-minute walk test
Time frame: 25 weeks
Sit to stand test
Time frame: 25 weeks
Extensor thrust during locomotor tasks
Time frame: 25 weeks
Fatigue
Time frame: 25 weeks
Likert Scale
Time frame: 25 weeks
Strength
Time frame: 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie HAMEAU, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic strength training of knee extensor and flexor muscles in people with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) and Gait Disorder, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie HAMEAU, PhD (299284218 ext. +33, sophie.hameau@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spontaneous walking speed (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.