Gait Perturbations to Improve Balance Post-stroke

Hemiparesis;Poststroke/CVA Clinical Trial

Official title:

Unpredictable Perturbations During Gait to Improve Balance Performance, Confidence and Participation in Persons With Hemiparesis at a Chronic Stage: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314830
• Other study ID #: CRIR-998-0914
• Status: Completed
• Phase: N/A
• Start date: August 5, 2016
• Est. completion date: October 30, 2018

Study information

• Verified date: March 2020
• Source: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Individuals with stroke have balance and gait deficits. Gait training does improve balance and gait abilities, but adding perturbations may have increase these effects. The objective was to compare the effect gait training with and without perturbations on balance and gait abilities in individuals with hemiparesis due to stroke at a chronic stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 30, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• able to walk at a comfortable speed less than 1.0 m/s

• have reduced dynamic balance capacities (as evaluated by the mini-BESTest; score below the 95% confidence interval of the mean score of the corresponding age group of normative data)

• with or without a history of fall

• be able to walk on a treadmill, without external support, such as handrails or walking aid, for at least 1 minute

Exclusion Criteria:

• hemineglect (more than 6 omissions on the bell cancellation test),

• cognitive impairment (Mini-Mental State Examination score under 24/30)

• uncorrected visual deficit or pathologies other than stroke which can affect their gait or balance

Related Conditions & MeSH terms

• Hemiparesis;Poststroke/CVA
• Paresis

Intervention

Device:
• Gait training with perturbations
Changes in speed of one of the belt of the split belt treadmill during swing phase
• Gait training without perturbation
Walking on a treadmill with steady belt speed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with gait perturbation intervention	Score at the Short Feedback Questionnaire. Rating from "Not at all" to "Extremely" to 9 questions. No total score. Answers interpreted for each question.	Within the week post-training
Other	Laboratory gait analysis : kinematics	Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations	Within the week pre-training
Other	Laboratory gait analysis : kinematics	Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations	Within the week post-training
Other	Laboratory gait analysis : kinetics	Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations	Within the week pre-training
Other	Laboratory gait analysis : kinetics	Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations	Within the week post-training
Other	Laboratory gait analysis : electromyographic activity	EMG activity of 5 muscle groups (tibialis anterior, soleus, rectus femoris, medial hamstring, paravertebral muscles at L3) bilateraly during gait at natural and fast speed and during gait perturbations	Within the week pre-training
Other	Laboratory gait analysis : electromyographic activity	EMG activity of 5 muscle groups (tibialis anterior, soleus, rectus femoris, medial hamstring, paravertebral muscles at L3) bilateraly during gait at natural and fast speed and during gait perturbations	Within the week post-training
Primary	Balance capacities	Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.	Within the week pre-training
Primary	Balance capacities	Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.	Within the week post-training
Primary	Gait capacities	Self-selected and fast gait speed measured over 10 meters (10 meter walking test)	Within the week pre-training
Primary	Gait capacities	Self-selected and fast gait speed measured over 10 meters (10 meter walking test)	Within the week post-training
Secondary	Paretic and non-paretic maximal knee extensor strength	Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex).	Within the week pre-training
Secondary	Paretic and non-paretic maximal knee extensor strength	Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex)	Within the week post-training
Secondary	Balance confidence	Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence	Within the week pre-training
Secondary	Balance confidence	Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence	Within the week post-training
Secondary	Balance confidence	Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence	6 weeks post training
Secondary	Community reintegration	Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.	Within the week pre-training
Secondary	Community reintegration	Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.	Within the week post-training
Secondary	Community reintegration	Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.	6 weeks post training