Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction

• Sponsor: Schulthess Klinik (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01901965
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

The main aims of the study are (1) to examine the impact of contralateral strength training on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of cross-education induced by NMES versus eccentric strength training.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness After Anterior Cruciate Ligament Reconstruction	Behavioral: Neuromuscular electrical stimulation; Behavioral: eccentric training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Could Contralateral Quadriceps Strength Training Attenuate the Strength Loss in the ACL-operated Knee?
• Study Start Date: May 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NMES neuromuscular electrical stimulation (NMES) of the quadriceps muscle with Kneehab	Behavioral: Neuromuscular electrical stimulation
Experimental: eccentric training unilateral eccentric resistance exercises	Behavioral: eccentric training
Sham Comparator: sham NMES neuromuscular electrical stimulation of the quadriceps muscle with intensity which causes no visible contraction or displacement of the leg (activation below motor threshold)	Behavioral: Neuromuscular electrical stimulation

Outcome Measures

Primary Outcome Measures

1. Change in bilateral quadriceps muscle strength [Nm] [1-2weeks preoperative/ 2weeks/ 8weeks/ 6month]

2. Change in quadriceps muscle activation [1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month]

Secondary Outcome Measures

1. Change in muscle architecture [1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month]

2. Change in self-reported questionnaire outcomes (KOOS, WOMAClk) [1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month]

3. functional test outcomes [6month postop]

   Assessment of present functional status by means of hop tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients scheduled for ACL reconstruction surgery

Exclusion Criteria:

• Concomitant lower limb injury or disorder

• previous lower extremity open surgery on the contralateral lower limb

• cardiac disease

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuromuscular Research Laboratory, Schulthess Klinik	Zurich	ZH	Switzerland	8008

Sponsors and Collaborators

• Schulthess Klinik

Investigators

• Principal Investigator: Nicola A Maffiuletti, PhD, Schulthess Klinik

Study Documents (Full-Text)

None provided.

More Information

Publications

• Feil S, Newell J, Minogue C, Paessler HH. The effectiveness of supplementing a standard rehabilitation program with superimposed neuromuscular electrical stimulation after anterior cruciate ligament reconstruction: a prospective, randomized, single-blind study. Am J Sports Med. 2011 Jun;39(6):1238-47. doi: 10.1177/0363546510396180. Epub 2011 Feb 22.
• Hortobágyi T, Scott K, Lambert J, Hamilton G, Tracy J. Cross-education of muscle strength is greater with stimulated than voluntary contractions. Motor Control. 1999 Apr;3(2):205-19.

• Responsible Party: Schulthess Klinik
• ClinicalTrials.gov Identifier: NCT01901965
• Other Study ID Numbers: Contralateral_01
• First Posted: Jul 17, 2013
• Last Update Posted: Apr 28, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Muscle Weakness

Study Results

No Results Posted as of Apr 28, 2015