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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD092614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.
Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL) reconstruction, and current rehabilitation approaches are not successful in optimizing quadriceps strength and knee function even years after the surgery. We hypothesize that suboptimal strength and functional outcomes after ACL surgery are due to the lack of task-specific exercise elements during strength training. This application seeks to assess whether progressive functional resistance training during gait will significantly improve quadriceps function, neural excitability, and knee mechanics during gait. The proposed studies will not only lay the foundation for a novel training paradigm, but will also improve our understanding of the mechanisms mediating neuromuscular and biomechanical changes after functional resistance training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Resistance Training with a Brace | Experimental | Participants will receive functional resistance training via a knee brace while walking on a treadmill 2-3 times a week for about 8 weeks. |
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| Functional Resistance Training with Elastic Band | Experimental | Participants will receive functional resistance training via an elastic band attached at the ankle while walking on a treadmill 2-3 times a week for about 8 weeks. |
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| Control | Sham Comparator | Participants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Resistance Training with Brace | Other | A brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Muscle Strength | Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated. | Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction. |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Voluntary Activation | Quadriceps voluntary activation was measured using the burst superimposition technique and calculated using the central activation ratio (CAR). The CAR formula is calculated using the peak torque generated immediately prior to the delivery of the stimulus (or the maximum voluntary isometric contraction, MVIC) being divided by the peak torque generated as a result of the electrical stimulus (MVIC plus superimposed burst) and then multiplied by 100. Equation is: MVIC/(MVIC + superimposed burst) × 100. A CAR of 100 represents complete volitional quadriceps activation. Voluntary activation was quantified immediately after the intervenapproximately 9-10 weeks after the int from baseline to the end of intervention will be assessed and compared between groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riann Palmieri-Smith, PhD | University of Michigan | Principal Investigator |
| Chandramouli Krishnan, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Resistance Training With Brace | Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill. |
| FG001 | Functional Resistance Training With Elastic Band | Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill. |
| FG002 | Control | Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Resistance Training With Brace | Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quadriceps Muscle Strength | Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated. | Posted | Mean | Standard Error | Nm/Kg | Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction. |
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Adverse event data was collected during the course of the study. The timeframe of the study was approximately 5 months. Adverse events during a period from about 8 weeks after ACL reconstruction to about 28 weeks after reconstruction.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Resistance Training With Brace | Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Riann Palmieri-Smith | University of Michigan | 734-615-3154 | riannp@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2018 | Nov 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2020 | Nov 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Control | Other | A brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill. |
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| Functional Resistance Training with Elastic Band | Other | An elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill. |
|
| Immediately after the intervention or approximately 18-20 weeks after ACL reconstruction |
| Knee Flexion Angle Symmetry | The knee flexion angle (measured in degrees) during the stance phase was gathered for both limbs using three dimension motion capture and recorded while subjects walked overground. A knee flexion angle symmetry score was computed using the following formula: ensemble average of knee flexion angle of ACL limb minus the ensemble average of knee flexion angle of the non-ACL limb. The mean difference between pre-intervention and post-intervention (post minus pre) knee flexion symmetry scores were calculated for each group. Higher values suggest greater increases in knee flexion angle symmetry from pre-intervention to post-intervention. | Pre-intervention values were recorded at ~9-10 weeks after ACL reconstruction and before the start of the intervention. Post-intervention values were recorded after the 8-week intervention (~18-20 weeks after ACL reconstruction) |
| Knee Moment Symmetry | The sagittal plane knee moment (units Nm) during the stance phase was gathered for both limbs using three dimensional motion capture and recorded while subjects walk overground. A symmetry score was computed using the following formula: ensemble average of the knee moment of the ACL limb (Nm) - ensemble average of the knee moment of the non-ACL limb (Nm). The mean difference between pre-intervention and post-intervention knee moment symmetry scores (post minus pre) were calculated for each group. Higher values represent the greater increases in knee moment symmetry from pre-intervention to post-intervention. | Pre-intervention scores were recorded prior to the start of the intervention and approximately 9-10 weeks after ACL reconstruction. Post-intervention scores were recorded after the 8 week intervention or approximately 18-20 weeks after ACL reconstruction |
| Functional Resistance Training With Elastic Band |
Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill. |
| BG002 | Control | Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Mass | Mean | Standard Deviation | kilograms |
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| Time Since Surgery to Baseline Study Testing | Mean | Standard Deviation | weeks |
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Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill. |
| OG002 | Control | Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill. |
|
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| Secondary | Quadriceps Voluntary Activation | Quadriceps voluntary activation was measured using the burst superimposition technique and calculated using the central activation ratio (CAR). The CAR formula is calculated using the peak torque generated immediately prior to the delivery of the stimulus (or the maximum voluntary isometric contraction, MVIC) being divided by the peak torque generated as a result of the electrical stimulus (MVIC plus superimposed burst) and then multiplied by 100. Equation is: MVIC/(MVIC + superimposed burst) × 100. A CAR of 100 represents complete volitional quadriceps activation. Voluntary activation was quantified immediately after the intervenapproximately 9-10 weeks after the int from baseline to the end of intervention will be assessed and compared between groups. | Posted | Mean | Standard Error | percentage of activation | Immediately after the intervention or approximately 18-20 weeks after ACL reconstruction |
|
|
|
| Secondary | Knee Flexion Angle Symmetry | The knee flexion angle (measured in degrees) during the stance phase was gathered for both limbs using three dimension motion capture and recorded while subjects walked overground. A knee flexion angle symmetry score was computed using the following formula: ensemble average of knee flexion angle of ACL limb minus the ensemble average of knee flexion angle of the non-ACL limb. The mean difference between pre-intervention and post-intervention (post minus pre) knee flexion symmetry scores were calculated for each group. Higher values suggest greater increases in knee flexion angle symmetry from pre-intervention to post-intervention. | Posted | Mean | 95% Confidence Interval | Angle Symmetry (degrees) | Pre-intervention values were recorded at ~9-10 weeks after ACL reconstruction and before the start of the intervention. Post-intervention values were recorded after the 8-week intervention (~18-20 weeks after ACL reconstruction) |
|
|
|
| Secondary | Knee Moment Symmetry | The sagittal plane knee moment (units Nm) during the stance phase was gathered for both limbs using three dimensional motion capture and recorded while subjects walk overground. A symmetry score was computed using the following formula: ensemble average of the knee moment of the ACL limb (Nm) - ensemble average of the knee moment of the non-ACL limb (Nm). The mean difference between pre-intervention and post-intervention knee moment symmetry scores (post minus pre) were calculated for each group. Higher values represent the greater increases in knee moment symmetry from pre-intervention to post-intervention. | Posted | Mean | 95% Confidence Interval | Moment Symmetry (Nm) | Pre-intervention scores were recorded prior to the start of the intervention and approximately 9-10 weeks after ACL reconstruction. Post-intervention scores were recorded after the 8 week intervention or approximately 18-20 weeks after ACL reconstruction |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Functional Resistance Training With Elastic Band | Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks. Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Control | Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill. | 0 | 10 | 0 | 10 | 0 | 10 |
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