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

NCT05520489 | Unknown

• 1 other identifier: satsairaalrehaba
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Keywords

rTMS, Robot Assisted Therapy, strokerehabilitation

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment

  Upper extremity motor, sensory, pain and movement assessment with higher value showing better results.

  3 weeks

• active range of motion in shoulder joint, elbow, wrist

  measured either by robotic device or goniometer; strength of hand and fingers (Jamar, Pablo) and shoulder proprioception (when the active movement of shoulder joint enabled assessment with laserpointer and target).

  3 weeks

Secondary Outcomes (6)

• Quality of life Eq-5D

  4 months

• Quality of life Eq-5D Visual Analogue Scale

  4 months

• International Classification of Function 15 Dimensions

  4 months

• World Health Organization Disability Assessment Schedule 2.0

  4 months

• Hospital Anxiety and Depression Score

  4 months

Study Arms (3)

treatment as usual, physiotherapy

ACTIVE COMPARATOR

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

Device: Repetitive Transcranial Magnetic stimulation; Device: Robot Assisted Therapy

Transcranial magnetic stimulation

ACTIVE COMPARATOR

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. 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; Other: Enhanced upper limb therapy programme

robot assisted training

ACTIVE COMPARATOR

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.

Device: Repetitive Transcranial Magnetic stimulation; Other: Enhanced upper limb therapy programme

Interventions

Repetitive Transcranial Magnetic stimulation DEVICE

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%.

robot assisted training; treatment as usual, physiotherapy

Robot Assisted Therapy DEVICE

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.

Transcranial magnetic stimulation; treatment as usual, physiotherapy

Enhanced upper limb therapy programme OTHER

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.

Transcranial magnetic stimulation; robot assisted training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults with hemiparesis/hemiplegia due to stroke (ischaemic or haemorrhagic)
• stroke diagnose within the previous 2-9 months (subacute phase)
• upper extremity Fugl-Meyer (FMA) motor score \< 56.

You may not qualify if:

• patient is unable to understand instructions
• transcranial magnetic stimulation contraindications (Rossi 2009, Rossini 2015)
• concurrent medical condition likely to worsen functional status within 6 months

Sponsors & Collaborators

• Satasairaala: lead

Study Sites (1)

dep of physical medicine and rehabilitation Satasairaala

Pori, 28100, Finland

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: January 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

FI (1)