Training of Eccentric Lower Extremity Function After SCI

Spinal Cord Injury Clinical Trial

Official title:

Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Intervention for Hip and Knee Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498548
• Other study ID #: 2014H0386
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: October 2019

Study information

• Verified date: March 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.

Description:

Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI. This proposal aims to characterize eccentric motor control of the muscles about the knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip joint during walking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Individuals with SCI:

Inclusion Criteria:

• medically approved

• discharged from outpatient rehabilitation for 6 months

• incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10

• ability to take some steps overground and on the treadmill

• 18-90 years old.

• ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.

Exclusion Criteria:

• evidence of lower motor neuron injury in the legs

• use of botox in the past 3 months

• pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)

• acute deep vein thrombosis

• skin wounds in regions where harness or hands provide support

• pregnancy. Note: Persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with SCI.

• cognitive conditions that preclude providing informed consent

• ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment

• persistent orthostatic hypotension (drop of BP >30mmHg in treadmill and harness equipment)

• hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study

• participation in any other concurrent exercise programs.

Note: Use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Behavioral:
• Trained SCI Knee or Trained SCI Hip
Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of knee control or hip control, members of this group will be trained at slow to moderate gait speeds.

Locations

Country	Name	City	State
United States	D Michele basso	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect)		baseline, 12 weeks
Other	Change from baseline in Neuromuscular Recovery Scale score		baseline, 12 weeks
Other	Change from baseline in balance function as measured by the Berg Balance Scale score		baseline, 12 weeks
Other	Change from Baseline in SCI specific Quality of Life score		baseline, 12 weeks
Other	Change from second baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)		12 weeks, 16 weeks
Other	Change from second baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)		12 weeks, 16 weeks
Other	Change from second baseline in peak magnitude of sagittal knee power absorption or frontal hip power during loading response		12 weeks, 16 weeks
Other	Change from second baseline in maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect)		12 weeks, 16 weeks
Other	Change from second baseline in Neuromuscular Recovery Scale score		12 weeks, 16 weeks
Other	Change from second baseline in balance function as measured by Berg Balance Scale score		12 weeks, 16 weeks
Other	Change from second baseline in SCI specific Quality of Life score		12 weeks, 16 weeks
Primary	Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)		baseline, 12 weeks
Secondary	Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)		baseline, 12 weeks
Secondary	Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading response		baseline, 12 weeks