Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Spinal Stabilization Exercises in Individuals With Transtibial Amputatıon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114175
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Senay Cerezci Duygu, Baskent University

Brief Summary:
Lower extremity amputation causes rapid changes in musculoskeletal system. With the effect of these changes, the energy requirement for prosthetic ambulance is much higher than normal ambulance. Although methods such as the reduction of the segmental load of the prosthesis and the preference of the different prosthetic components for energy expenditure have been emphasized, the effect of exercise types has not been investigated in our knowledge. Therefore, the aim of the current study is to investigate the effect of spinal (Core) stabilization exercises on energy expenditure in combination with the classical physiotherapy program in patients with unilateral transtibial amputation. Individuals with transtibial amputation included in the study will be randomly divided into two groups. In group 1, basic exercises related to amputation will be applied for 8 weeks and in group 2 basic exercises with spinal stabilization exercises will be applied to the individuals. At the beginning and at the end of the exercise intervention, energy expenditure and exercise capacity will be evaluated by a portable exercise test device during '6 Minutes Step Test'; fatigue assessment will be done before and after 6 Minutes Step Test with 'Modified Borg Scale'; the strength of deep spinal muscles will be evaluated with 'Stabilizer'; dynamic balance and functional mobility will be evaluated by 'Timed Up & Go' Test; and the effect of the prosthesis on mobility will be evaluated by the sub-scale 'Mobility' of 'Prosthetic Evaluation Questionnaire'.

Condition or disease Intervention/treatment Phase
Amputees Exercise Training Physiotherapy Energy Metabolism Other: Exercise BE Other: Exercise BE+SS Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Spinal Stabilization Exercises on Energy Expenditure in Individuals With Transtibial Amputatıon
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization.
Other: Exercise BE
Basic exercises related to amputation will be applied

Experimental: Spinal Stabilization Group
People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization.
Other: Exercise BE+SS
Basic exercises related to amputation + Spinal stabilization exercises will be applied




Primary Outcome Measures :
  1. Energy expenditure and exercise capacity [ Time Frame: 6 minutes ]
    Assessement will be with the exercise tester (COSMED, Fitmate Pro, Rome, Italy) during the 6 Minute Step Test .


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 20 seconds ]
    Assessement will be with "Modified Borg Scale" after 6 Minute Step Test. Pariticipants were shown the Modified Borg Scale, which is a vertical scale from 0 to 10 in which numbers are anchored with corresponding verbal expressions of progressively increasing intensity. The patients were asked to rate their fatigue by selecting the number with the corresponding words that most appropriately described their sensation of fatigue. The minimum value that can be obtained as a result of the evaluation is 0 (Nothing at all), the maximum value is 10 (Maximal).

  2. Strength of deep spinal muscles [ Time Frame: 3 minutes ]
    Assessement will be with "Stabilizer".

  3. Mobility [ Time Frame: 5 minutes ]
    Prosthesis Evaluation Questionnaire (PEQ) was designed as a self-report visual analog scale style questionnaire with scores expressed in millimeters (0-100 mm). PEQ was previously translated to Turkish language, and it was proven to be valid and reliable. The questions of the PEQ are organized into nine functional domain scales, each reflecting a major area of concern for persons with amputations, such as "mobility". Each domain scale can be used and scored independent of the others. All subscales are scored between 0 and 100 (for example, in mobility subscale higher scores indicate higher mobility). In mobility subscale there are 13 questions. The minimum value that can be obtained as a result of the evaluation is 0 (minimum mobility), the maximum value is 130 (maximum mobility).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having unilateral transtibial amputation of at least 6 months in which the stump volume becomes stable,
  • Being prosthetic users (For homogenization of the groups in terms of external support used, individuals with transitibial amputation included in the study should use total contact socket and carbon foot prosthesis systems - Pin System, Passive Vacuum System or Active Vacuum System),
  • Having at least "four" quadriceps and hamstring muscle strength in the amputated limb according to Lovett's manual muscle test method.

Exclusion Criteria:

  • Having any disadvantage about prosthetic device usage in terms of stump length, shape and edema,
  • Having movement limitation,
  • Having phantom pain in the stump,
  • Having any discomfort or health problem (cardiopulmonary, neurological or orthopedic problems) that may affect gait other than amputation,
  • Having multiple extremity loss.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114175


Contacts
Layout table for location contacts
Contact: Senay Cerezci Duygu, MSc 05369128768 senaycerezci@gmail.com

Locations
Layout table for location information
Turkey
Baskent University Recruiting
Ankara, Turkey, 06790
Contact: Senay Cerezci    05369128768    senaycerezci@gmail.com   
Sponsors and Collaborators
Baskent University
Hacettepe University
Investigators
Layout table for investigator information
Study Chair: Fatih Erbahceci, Prof Hacettepe University
Study Director: Senay Cerezci Duygu, MSc Baskent University

Layout table for additonal information
Responsible Party: Senay Cerezci Duygu, Research Assistant, Baskent University
ClinicalTrials.gov Identifier: NCT04114175    
Other Study ID Numbers: KA19/143
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Senay Cerezci Duygu, Baskent University:
amputees
rehabilitation
energy expenditure
deep muscles of the back