The effect of functional electrical stimulation (FES) in reconstructive hand and arm surgery in tetraplegic patients

Summary description of the study

Functional electrical stimulation (FES) is an established method in the rehabilitation of people with spinal cord injury. In FES, electrodes applied to the skin deliver current to the muscle, causing it to contract. Through FES training, effects such as avoidance and reduction of muscle atrophy, increase in muscle strength, performance, and endurance can be achieved. The aforementioned effects of FES gain additional significance when considering reconstructive arm and/or hand surgery in tetraplegic patients. The aim of the study is to examine whether pre-treatment with FES and the integrated application of FES into standardized physiotherapy and occupational therapy treatment in patients undergoing reconstructive arm and hand surgery show an advantage in the use of the arm/hand. This is a controlled randomized study. This means that there are two groups, with random assignment to the groups: 1. Group "Group with FES and physiotherapy and occupational therapy treatment" 2. Group "Group with physiotherapy and occupational therapy treatment" A total of 30 individuals will be included in the study, 15 per group. Additionally, in both groups, tests will be conducted before and after the operation to verify the treatment method. The tests will take place depending on group assignment at 4-5 measurement points. For group 1, the total study duration is 32 weeks. For group 2, it is 24 weeks. All stimulation devices used in the study are CE certified and are routinely used for stimulation in the rehabilitation of people with spinal cord injury.

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Intervention under investigation

Before the operation, the donor muscle for group 1 is stimulated for 8 weeks, 3 times a week for 30 minutes. For this purpose, surface electrodes are applied to the skin over the corresponding muscle. The stimulation supports the contraction of the muscle. During stimulation, exercises are performed, such as lifting the arm against gravity or supporting oneself on the arm. Before and after this 8-week stimulation, various tests are conducted to verify whether the stimulation has resulted in an increase or improvement in the strength and functionality of the muscle and its muscle volume. Additionally, a questionnaire is used to assess the subjective benefit of the stimulation and the feasibility of its application. After the operation, following a 4-week immobilization period, during which the hand is mobilized through physiotherapy and occupational therapy, stimulation is resumed for group 1. In combination with the standard physiotherapy and occupational therapy treatment, stimulation of the shifted muscle in its new function is performed daily for 30 minutes for 12 weeks. EMG-triggered means that the existing activity of the muscle is measured through surface electrodes, and when activity begins, stimulation is added to support and enhance the activity. This is intended to support and accelerate the process of learning the new function of a muscle. Additionally, 3 times a week, as part of the therapy where muscle-strengthening exercises are performed, these are supported by FES. Here too, tests are conducted at the beginning and after 12 weeks of training. Group 2 does not perform any training before the operation. After the operation, this group receives standardized physiotherapy and occupational therapy treatment, but without FES. The execution of the tests is the same, except for the first test, which is only conducted by group 1 at the beginning of the FES training before the operation. The questionnaire assessing the subjective benefit and feasibility of FES is also omitted for group 2. In both groups, the driving force while wheelchair riding is measured 24 weeks after the operation.

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Disease under investigation

Limitations in the function of the arms and hands in patients with tetraplegia

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Sponsor

Ursina Arnet Swiss Paraplegic Research 6207 Nottwil

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Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee northwest/central Switzerland EKNZ

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Date of authorisation

28.01.2017

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Results of the trial