Ambulation performance in chronic stroke patients using an implanted drop foot stimulator

Ambulation performance in chronic stroke patients using an implanted drop foot stimulator - AMPECS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32078

Enrollment

Registered

2008-05-29

Start date

2008-12-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central motor neuron lesion

Interventions

Surgical intervention of an inerve stimulating device which consists of 2 parts. The electrodes are fixed on the nerve and the receiver is placed subcutaneously. The pulse generator is placed on the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * age >

Exclusion criteria

Exclusion criteria: * pacemaker * any medical condition that would exclude the use of a surgical procedure or anaesthetic * pregnancy * inability to read or understand Dutch or receptive aphasia? * no informed consent

Design outcomes

Primary

Measure	Time frame
Primary outcome measures: * Gait parameters: walking speed, gait symmetry, gait width, foot placement,cadence,gait fluency, * Two minute walking test (Brooks 2001, Datta 1996) * Functional gait performance: - outdoor circuit with different surface textures (Kölgen et al., 2002), indoor participation circuit (Hemmen et al., 2007; Stevens et al., 2006; Ilmer et al., 2007) - Family Qol & Stroke specific utlities.(see attachment) - Generic quality of life: SF-36 (vd Zee et al., 1993)	—

Measure

Time frame

Primary outcome measures: * Gait parameters: walking speed, gait symmetry, gait width, foot placement,cadence,gait fluency, * Two minute walking test (Brooks 2001, Datta 1996) * Functional gait performance: - outdoor circuit with different surface textures (Kölgen et al., 2002), indoor participation circuit (Hemmen et al., 2007; Stevens et al., 2006; Ilmer et al., 2007) - Family Qol & Stroke specific utlities.(see attachment) - Generic quality of life: SF-36 (vd Zee et al., 1993)

—

Secondary

Measure	Time frame
Secondary outcome measures: * * Functional health status: Functional Independence Measure (FIM) (Kidd et al., 1995) * Anxiety and depression: HADS (Spinhoven et al., 1997) Cognitive functioning: MMSE (Jackson et al., 2007) * Functional health status, . Functional independence measure (FIM) * Credibility/expectancy questionnaire (CEQ) (Devilly & Borkovec, 2000)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)