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NCT05133232Befejeződött

Effect of SynPhNe Physio-neuro Platform on Hand Motor Function Rehabilitation of Acute and Subacute Stroke Patients

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 23.

Rövid összefoglaló (regiszter, angolul)

Stroke is a major cause of adult long term disability and the fourth leading cause of death and affects 1·8/1000 persons in Singapore. Post-stroke functional recovery of upper limb is poor with 80% of stroke survivors having some upper limb disability during the acute to subacute phase after stroke. Early rehabilitation is paramount for enhancing the survival and independence of stroke patients and inadequate supervised therapy hours is closely associated with poor rehabilitation outcome. However, high intensity and high repetition therapies, which facilitates neuroplasticity, have historically had a poor uptake because it is manpower intensive and places a high demand on stroke patients, many of whom cannot cope. High fatigue and sustained levels of effort are also generally perceived as placing the patient at risk if done at home without trained supervision. Robotic rehabilitation system can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress. Stroke subjects also have a wide spectrum of disability resulting in unconscious co-contractions and compensatory muscle use. Although these disability elements are widely acknowledged to be present, technological tools for identifying and quantifying these are missing. This technology gap affects the optimization of therapy and the patients' understanding of their condition. This study aims: 1. To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time, compared with conventional occupational therapy alone, on hand motor function in acute and subacute stroke patients; 2. To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision; 3. To investigate subject and staff perceptions in terms of usability and benefit of the device; 4. To study clinical outcomes, EEG, EMG and TMS changes over the course of the study; 5. To compare the cost-benefit of SynPhNe therapy on inpatients with standard care. Hypotheses: 1. SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients; 2. SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased; 3. SynPhNe therapy is a cost-effective inpatient rehabilitation option.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
51 (tényleges)
Első benyújtás
2020. aug. 19.
Kezdés
2019. júl. 4.
Elsődleges befejezés
2025. okt. 6.
Fő szponzor
National University Hospital, Singapore
NCT-szám
NCT05133232

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 51
  • 2019. júl. 4. és az elsődleges befejezés (2025. okt. 6.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Cognitive or language impairment resulting in inability to follow instructions or inability to sustain attention for more than 10 minutes or inability to give consent;
  • Other orthopaedic or neurological diseases other than stroke affecting the function of the stroke-affected arm;
  • severe pain in the stroke affected upper limb
  • Terminal diseases with expected survival \<1 year
  • Patients who are in medically unstable conditions.

Egyéb

  • Poor sitting balance (inability to sustain unsupported sitting for \> 10min)
  • Women who are pregnant or breastfeeding

Kiket keres a vizsgálat

  • Hemiparetic stroke (haemorrhagic or ischaemic) within 4 months of recruitment;
  • FMA UE less than 55 (out of maximum of 66) but able to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow;
  • Age 21-90.

Életkor a regiszterben: 21 év – 90 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Alexandra Hospital
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SingaporeSzingapúrIsmeretlen állapot

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