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Acute effect of a manual therapeutic treatment in subjects with chronic ankle instability on muscle activation and postural control - a randomized controlled study

Organizational Data

DRKS-ID:
DRKS00012300
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-04-10
Last update in DRKS:
2017-04-10
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

No Entry

Brief summary in scientific language

The capsule and the ligaments contain mechanoreceptors (Golgi tendon organs, Ruffini and Vater-Pacini bodies) and free nerve endings. These have different somatosensory tasks in the area of afferent information transfer of the joint position to the central-nervous-system (CNS). If they are impaired in their function by an injury, for example in the case of a ankle joint distortion, it can be assumed that the control loop between afferent and efference no longer functions correctly. This may lead to altered proprioception and postural control (Hertel, 2002; Hubbard & Hertel, 2006; McCriskin et al., 2015). Hopkins (2009) postulated that patients with CAI show a longer latency of the peroneus longus muscle during walking and altered activation patterns in a jump. In addition, deficits in sensorimotor and postural control are described in patients with CAI (Munn et al., 2010; Steib & Pfeifer, 2015). Passive ankle mobilization and ankle manipulation improves the range of motion of the ankle joint (Loudon, Reiman, & Sylvain, 2014; Marron-Gomez, Rodriguez-Fernandez, & Martin-Urrialde, 2015). It can also be assumed that mobilization affects the mechanoreceptors of the capsule (Baeske, 2016). It can be assumed that the mechanoreceptors in the capsule are affected by passive joint mobilization, resulting in improved information transfer, which can improve muscle activation and postural control. This effect would also be desirable in patients with a CAI. Based from that described above, this study examine short-term effects after an unique manual ankle mobilization on muscle activation of the leg muscles and the postural control in patients with CAI.

Health condition or problem studied

ICD10:
S93 - Dislocation, sprain and strain of joints and ligaments at ankle and foot level
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
The participants will get an intervention (mobilization): The mobilization thrust direction is from anterior to posterior in a final degree of dorsiflexion of the talocruralis joint. Mobilization: during 5 x 1 minute, each with an ease-off of 10 seconds in between. In a Grade III mobilization to Maitland, a passive movement is performed, which has a large amplitude and enters the resistance. It is measured before and after the intervention.
Arm 2:
The participants sit on a chair for 10 minutes. Before and after the rest a measurement will be performed.

Endpoints

Primary outcome:
M. peroneus longus activation during the landing from one-leg-drop-jump before and after a mobilization treatment of the ankle joint. The measurement will be carried out with the EMG device NORAXON TeleMyo 2400T G2 and one-way electrodes Ambu® Blue-Sensor.
Secondary outcome:
Evaluation of the 1. Time-to-stabilization in post-one-leg drop-jump assessment as a parameter for postural control. The anterior / posterior, the medial / lateral and the vertical ground reaction force with a sampling frequency of 1000 Hz are recorded as values using a force measuring plate (Kistler Quattro Jump, Sindelfingen, Germany), whereupon the TTS is calculated. 2. Muscle activation of the tibialis anterior, soleus, gastrognemius, quadriceps femoris, biceps femoris during landing after one-leg-drop-jump. The measurement will be carried out with the EMG device NORAXON TeleMyo 2400T G2 and one-way electrodes Ambu® Blue-Sensor. 3. Reliability measurement of time-to-stabilization.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
II-III
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Data analyst
  • Investigator/therapist

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Berner Fachhochschule, Departement Gesundheit, Disziplin Physiotherapie Bern

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2017-04-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
142
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
40 Years
Additional Inclusion Criteria:
Participants with a chronically unstable ankle between 18 and 40 years of age, one injury (distorsion trauma) ≥1 year ago, Identification of functional instability (IdFAI) ≥ 11 points, questions 5 and 6 of the IDFAI are not answered with "never" In the sense of the investigation.

Exclusion Criteria

Lower limb injuries during the last 3 months, due to which physical activity was not possible for more than one day, surgery on the affected lower extremity in the last 12 months, surgery on the affected ankle, neurological or peripheral vascular disease, medication with influence On the balance, therapeutic treatment on the lower limb and back (eg physiotherapy or osteopathy) during the duration of the study, acute infections, fever.

Addresses

Primary Sponsor

Address:
Berner Fachhochschule, Departement Gesundheit, Disziplin Physiotherapie
Dr. Slavko Rogan
Murtenstrasse 10
3008 Bern
Switzerland
Telephone:
+41 31 848 35 56
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.gesundheit.bfh.ch/de/ueber_uns/kontakt/detailseite.html?tx_bfhpersonalpages_p=rgs2&tx_bfhpersonalpages_screen=data&cHash=cb9a0ae9354f49b652044ac601391a30
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Berner Fachhochschule, Departement Gesundheit, Disziplin Physiotherapie
Dr. Slavko Rogan
Murtenstrasse 10
3008 Bern
Switzerland
Telephone:
+41 31 848 35 56
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.gesundheit.bfh.ch/de/ueber_uns/kontakt/detailseite.html?tx_bfhpersonalpages_p=rgs2&tx_bfhpersonalpages_screen=data&cHash=cb9a0ae9354f49b652044ac601391a30

Contact for Public Queries

Address:
Berner Fachhochschule, Departement Gesundheit, Disziplin Physiotherapie
Dr. Slavko Rogan
Murtenstrasse 10
3008 Bern
Switzerland
Telephone:
+41 31 848 35 56
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.gesundheit.bfh.ch/de/ueber_uns/kontakt/detailseite.html?tx_bfhpersonalpages_p=rgs2&tx_bfhpersonalpages_screen=data&cHash=cb9a0ae9354f49b652044ac601391a30

Principal Investigator

Address:
Berner Fachhochschule, Departement Gesundheit, Disziplin Physiotherapie
Dr. Slavko Rogan
Murtenstrasse 10
3008 Bern
Switzerland
Telephone:
+41 31 848 35 56
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.gesundheit.bfh.ch/de/ueber_uns/kontakt/detailseite.html?tx_bfhpersonalpages_p=rgs2&tx_bfhpersonalpages_screen=data&cHash=cb9a0ae9354f49b652044ac601391a30

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Berner Fachhochschule, Departement Gesundheit, Disziplin Physiotherapie
Murtenstrasse 10
3008 Bern
Switzerland
Telephone:
+41 31 848 35 56
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.gesundheit.bfh.ch/de/ueber_uns/kontakt/detailseite.html?tx_bfhpersonalpages_p=rgs2&tx_bfhpersonalpages_screen=data&cHash=cb9a0ae9354f49b652044ac601391a30

Ethics Committee

Address Ethics Committee

Address:
Kantonale Ethikkommission Bern (KEK) [Kantonale Ethikkommission Bern (KEK) www.kek-bern.ch ]
Murtenstr. 31
CH-3010 Bern
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.kek-bern.ch/

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2017-02-21
Ethics committee number:
BASEC 2017-00203
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-03-30

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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