Upper Limb Rehabilitation in First Year After Stroke Using Modern Treatment Strategies - a Single Case Study

NCT05520489 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-30

No results posted yet for this study

Summary

Stroke is a major cause of disability in worldwide, causing billions of euros direct and indirect costs to the community. Upper limb motor dysfunction is seen in about 50% stroke survivors. Upper extremity paresis is identified as a strong component for performing activities of daily living (ADL) (Veerbeek 2011). Upper-limb rehabilitation is crucial during the first three to six months since the onset of stroke because the motor and ADL-performance recovery of stroke survivors declines afterward (Kwakkel \& Kollen, 2013, Wade et al., 1983). The main advantages of using robot-assisted therapy are to deliver high-dosage and high-intensity training (Sivan et al., 2011). Robot-assisted training enables a greater number of repetitive tasks to be practised in a consistent and controllable manner. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke (Pollock 2014) and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke.

Repetitive transcranial magnetic stimulation (rTMS) is the field of interest and is incorporated to stroke rehabilitation in many institutes. Low-frequency rTMS to the unaffected hemisphere could normalize the inhibitory imbalance between hemispheres (Adeyemo et al., 2012). The safety and application guidelines of transcranial magnetic stimulation were extensively reviewed by Rossi et al. (2009). It is opposed that there is no effect of rTMS alone on upper extremity (UE) disabilities, but rTMS in combination with another rehabilitation treatment potentiates the effect of the rehabilitation treatment alone with regards to UE impairment. There is inconclusive evidence that the combined treatment (rTMS + conventional rehabilitation) have effect on UE disabilities. Treatment effects have been described in acute, subacute and chronic stroke patients, though it is proposed, that there is lack of late subacute phase rTMS studies that used FMA for outcome measure (van Lieshout, 2019).

In this single-case study the investigators compare different rehabilitation modules - self exercising (baseline), robot assisted training, rTMS and intensive motor training guided by therapist, to improve the use of paretic hand. The aim of this study is to show if there is clinically relevant improvement of the motion or function of upper extremity in different treatment strategies and if any of these treatment is superior to self-training.

Conditions

Interventions

DEVICE

Repetitive Transcranial Magnetic stimulation

Participants received 15 sessions (15 daily session - Monday to Friday) of active rTMS over the 'hotspot" M1 area of the unaffected hemisphere leading to a response in the contralateral thenar muscle using Visor2-navigation system and MagstimRapid -magnetic stimulator. . "Hot spot" localization was performed by stimulation with 50%:n intensity and found the maximum response area, where the coil was placed using the navigator cursor. The motor threshold was found using Maximum-Likelihood Strategy -algorithm of MTAT system. Low frequency rTMS was applied at 80-90% resting motor threshold (rMT) intensity, 1 Hz, 600+600 pulses, inbetween 10 minutes break. Intensity was increased after each 2-3 treatment to keep motor threshold 90%.

DEVICE

Robot Assisted Therapy

This was delivered using the Diego and Pablo (Tyromotion GmBH) robotic gym system. Participants receive robot-assisted training for up to 60 min per day, four days per week for 3 weeks, in addition to usual care. Robotic devices enable 3D interactive exercising, using weight reducing system in Diego and fine motor training in Pablo. Exercises can be one- or two-handed and/or symmetrical. Patient performs 150-400 repetitions in one therapy session. Estimated time is 2-3 minutes per one exercise section. Standard "minimum" program includes 4 games: "swimming", "shooting", "ship" and "apple orchard". The therapist instructs the patient and assure the position of trunk and shoulder girdle.

OTHER

Enhanced upper limb therapy programme

Exercises were performed by using different objects for task orientated movements. The therapist provided assistance as needed and encouraged participants to complete the tasks. Training was divided to 3 sessions for fine motor training and complex training and 1 session for shoulder girdle and complex training per week for 3 weeks, in addition to usual care. Each session lasts 1 hour and estimated time is 2-5 min to each exercise section.

Sponsors & Collaborators

  • Satasairaala

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-05-31
Completion
2023-12-31

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05520489 on ClinicalTrials.gov