An interventional study of Exercise BE and Exercise BE+SS in Amputees, Exercise Training and Physiotherapy, sponsored by Baskent University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Baskent University · Not applicable, Interventional, and Supportive care
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'.
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Exclusion Criteria:
People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization.
Other: Exercise BE
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 will be applied
Basic exercises related to amputation + Spinal stabilization exercises will be applied
Energy expenditure and exercise capacity
Assessement will be with the exercise tester (COSMED, Fitmate Pro, Rome, Italy) during the 6 Minute Step Test .
Time frame: 6 minutes
Fatigue
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).
Time frame: 20 seconds
Strength of deep spinal muscles
Assessement will be with "Stabilizer".
Time frame: 3 minutes
Mobility
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).
Time frame: 5 minutes
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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