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The goal of this clinical trial is to determine the effect of treatment frequency on the physical recovery of adults with incomplete spinal cord injury. The treatment will last for eight weeks and will occur either either two or three times weekly. The main research questions are:
The researchers will compare people receiving treatment two vs. three times per week to see if they differ in the amount of change seen in muscle strength, level of independence performing a functional task requiring use of the targeted muscle group, and/or perceived exertion required to perform the functional task.
Participants will:
Participants in both treatment groups will receive blood flow-restricted (BFR) intervention for eight weeks. Other than substituting BFR exercises for those typically performed with the target muscle group, a participant's established treatment program will not change with study enrollment.
Participants will engage in pre-treatment data collection measuring the strength and functional use of the target muscle group for three consecutive days before beginning the BFR protocol. We will use a dynamometer to measure in Newtons the maximum force a participant can exert with the left and right target muscle. To measure functional use, we will assess the assistance a participant needs to perform a designated functional task using the Functional Independence Measure (FIM) rating scale. Participants will rate their perceived effort with the Borg category-ratio 10 Rating of Perceived Exertion (Borg) scale.
Each BFR exercise session will begin with measuring resting blood pressure to ensure it is between 80/50 mmHg and 150/90 mmHg. We will then place a 50% inflated pneumatic cuff either with or without an electrical stimulation (ES) device, as appropriate, on the participant's target limb. The participant will perform 4 sets of 20 low-dose contractions of the target muscle with 30 s rest between sets. We will only use ES supplementation when a participant can not perform additional set repetitions independently. Resistance band placement will increase repetition difficulty as strength increases. The treatment regimen will then repeat with the contralateral limb.
We will repeat the measurement of muscle strength and functional task performance for three consecutive days at the conclusion of the eight-week treatment regimen. Again, we will rate the assistance provided for functional task performance using the FIM scale, and the participant will report the effort exerted using the Borg scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two times per week | Active Comparator | Participants will received blood flow-restricted exercise treatment two times per week for eight weeks. Treatment will target one muscle group both on the left and right side of the body. Participants will complete four sets of 20 muscle contraction repetitions with a 30-second rest period between each set. If a participant can not complete all 20 repetitions in a set, they will receive electrical stimulation to the muscle to prompt performance of the remaining set contractions. |
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| Three times per week | Active Comparator | Participants will received blood flow-restricted exercise treatment three times per week for eight weeks. Treatment will target one muscle group both on the left and right side of the body. Participants will complete four sets of 20 muscle contraction repetitions with a 30-second rest period between each set. If a participant can not complete all 20 repetitions in a set, they will receive electrical stimulation to the muscle to prompt performance of the remaining set contractions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow-restricted exercise | Behavioral | Blood flow-restricted exercise involves performance of low-load contractions of a target muscle group while a pneumatic cuff placed proximally on the limb partially restricts blood flow to muscles and venous return to central circulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Torque in Newton-meters | Rotational force exerted when contracting the target muscle group | Three consecutive days pre- and post-treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure rating | The Functional Independence Measure (FIM) is a seven-point scale (i.e., 1=total assistance, 7=complete independence) for quantifying the support needed for a participant to perform a designated functional task. | Three consecutive days pre- and post-treatment |
| Borg category-ratio 10 Rating of Perceived Exertion scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Hux, Ph.D. | Quality Living, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quality Living, Inc. | Omaha | Nebraska | 68104 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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The Borg category-ratio 10 Rating of Perceived Exertion scale (Borg) provides a means for participants to rate their perceived effort during functional task performance (0=no exertion; 10=highest effort possible). |
| Three consecutive days pre- and post-treatment |
| D014947 | Wounds and Injuries |