Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury

NCT ID: NCT05200091

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2022-12-31

Brief Summary

The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.

Detailed Description

After obtaining their consent, participants will undertake evaluations at different times:

1. Assessment 1 week prior to training

2. Training over 4 weeks (nature of the training depends on the group)

3. Assessment 1 week after training

4. Assessment 1 month after training (follow-up)

Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:

• Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
• Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.

After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined explosive strength and specific balance training group

This group will be formed with participants with incomplete spinal cord injury. This group will perform 4 weeks of combined explosive strength and specific balance training.

Group Type: EXPERIMENTAL

Combined explosive strength and specific balance training group

Intervention Type: OTHER

Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations.

Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements.

Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:

• Forward tilt of base of support;
• Backward tilt of base of support;
• Translation forward;
• Translation backward;
• Without moving their feet, participants will have to move their avatar to reach different targets placed around them on the screen, at different distance from the center.

Spinal cord injury control group

This group will be formed with participants with incomplete spinal cord injury. They will perform all the evaluation before and after a 4-week period of rest (no training).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy control group

Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Combined explosive strength and specific balance training group

Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations.

Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements.

Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:

• Forward tilt of base of support;
• Backward tilt of base of support;
• Translation forward;
• Translation backward;
• Without moving their feet, participants will have to move their avatar to reach different targets placed around them on the screen, at different distance from the center.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have an incomplete lesion of spinal cord
• Level of spinal cord lesion between C5 and T12
• At least, 6 months post-injury
• Be considered as AIS C or D
• Be able to stand without support for 15 seconds
• Be able to provide informed consent in English or in French

Exclusion Criteria

• To have cognitive deficits
• To have personal or family history of epilepsy
• To have suffered moderate or severe traumatic brain injury
• To have cochlear implant

FOR CONTROL PARTICIPANTS

• To have orthopedics problems
• To have cognitive deficits
• To have neurological problems

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

OTHER

Sponsor Role: lead

Responsible Party

Dorothy Barthélemy

Associate professor and researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neuromobility lab

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dorothy Barthélemy, PhD, PT

Role: CONTACT

dorothy.barthelemy@umontreal.ca

514-343-7712

Facility Contacts

Dorothy Barthélemy, PhD, PT

Role: primary

dorothy.barthelemy@umontreal.ca

514-343-7712

Other Identifiers

CRIR 1325-0118

Identifier Type: -

Identifier Source: org_study_id